Explore every episode of the podcast Automating Quality
| Title | Pub. Date | Duration | |
|---|---|---|---|
| Episode 60: Investigative Methods with Michael Tyo | 05 Nov 2024 | 00:18:34 | |
Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management. In today’s episode, Michael and Philippe discuss investigation methods, how to apply them in detail, and the various tools available for conducting investigations.
Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting.
Key Takeaway 01:24 Introducing today’s guest: Michael Tyo 01:55 Today’s topic is investigative methods and what happens when things go wrong 03:36 The Fishbone method 06:28 Why human error cannot be a root cause? 07:55 The 5 Whys method 09:35 What needs to be included in the investigation report? 11:30 What does the FDA expect from investigations? 12:38 Lessons from recent FDA’s warning letters
Contact Michael at mtyo@tyobio.com, Tyo Biotechnology Consulting Contact solabs at solabs-podcast@solabs.com | |||
| Episode 59: Introduction to Investigations with Michael Tyo | 01 Oct 2024 | 00:18:31 | |
Automating Quality Episode 59 – Inspection Readiness with Michael Tyo
Welcome to Automating Quality, the Life sciences-centric show that bridges the gap between automation and quality. In today’s episode, we discuss inspection readiness, from why we are doing them to how to conduct investigations properly.
Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting.
Key Takeaways 00:42 Introducing today’s guest: Michael Tyo 01:42 Today’s subject is the investigations, from why they exist to how they must be performed 02:22 Why are we doing investigations? 04:21 What may trigger an investigation? 08:04 What must be investigated? 10:00 Who is responsible for doing investigations? 14:41 What are the tasks once the investigation is launched?
Contact Michael at mtyo@tyobio.com, Tyo Biotechnology Consulting Contact solabs at solabs-podcast@solabs.com | |||
| Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve | 01 Aug 2023 | 00:16:06 | |
Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very special 50th episode! We are joined today by Jamie Villeneuve, CEO and Head of Software Development at NexGen Analytics. Jamie will discuss the common challenges GMP shopfloor companies have in terms of analytics, how this evolved over time, and more!
Key Takeaways 01:01 Introducing today’s return guest: Jamie Villeneuve from NexGen Analytics 02:35 What are some of the common challenges in GMP companies from an analytics standpoint? 05:01 What departments need input from analytics? 07:31 How has analytics evolved over time for GMP companies? 10:11 New nomenclature and approach for analytics 11:38 Why do companies invest more and more in analytics? 13:03 The top 5 metrics GMP shopfloor analytics companies need to track 14:42 Thank you to Jamie for joining us for this special episode #50! Contact Jamie at jvilleneuve@solabs.com Contact us at solabs-podcast@solabs.com | |||
| Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve | 04 Jul 2023 | 00:16:07 | |
Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode!
We are joined today by Jamie Villeneuve, Owner and Head of Software Development at NexGen Analytics. Jamie will discuss the design of analytics from establishing the organization's goals to providing the right information to the right people at the right time.
Key Takeaways 01:58 Introducing today’s guest: Jamie Villeneuve from NexGen Analytics 03:19 Who needs information from analytics in an organization? 05:36 How do you know what information is relevant to report on? 08:52 How do you communicate analytics effectively to all staff at a company? 11:40 Is there a process to review metrics over time and ensure what is measured stays up to date with the company’s needs? 15:12 Thank you to Jamie for joining us!
Contact Jamie at jvilleneuve@solabs.com Contact us at solabs-podcast@solabs.com | |||
| Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia | 02 May 2023 | 00:14:18 | |
Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode!
We are joined today by return guest Joseph Silvia, Director, Software Quality Training, and Instructor at Oriel STAT A MATRIX. In this episode, Joe shares his expertise on Supplier Management Quality for the medical devices industry. We discuss the onboarding process of new suppliers, the future of remote versus on-site audits, and more!
Key Takeaways 00:38 Introducing Joseph Silvia and Oriel STAT A MATRIX 02:53 Who are the main parties involved in the medical devices supply chain? 04:15 What is the process to getting a new supplier on board? 07:56 Are all audits in the future going to be remote? 10:04 Do suppliers change their processes to make themselves easier to audit? 12:55 Thanks to Joseph and our listeners for this great episode! | |||
| Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia | 04 Apr 2023 | 00:19:02 | |
Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode!
Our guest today is Joseph Silvia, Director, Software Quality Training and Instructor at Oriel STAT A MATRIX. Joe shares his expertise on the Case for Quality, what to focus on first when implementing a quality system and the differences between Computer Software Validation (CSV) and Computer Software Assurance (CSA), and more!
Key Takeaways 02:17 Introducing today’s guest: Joseph Silvia, Director of Software Quality Training and Instruction and Lead Auditor at Oriel Stat A Matrix 03:33 What is the Case for Quality? 05:23 Joseph discusses the importance of having quality at the core of what you do as opposed to adding it as an afterthought 07:44 What is the first thing you should focus on when implementing a quality system? 10:55 Philippe shares his experience on implementing QM10 at SOLABS as part of our quality practices 12:53 The difference between Computer Software Validation (CSV) and Computer Software Assurance (CSA) and how this is impacting risk management 17:38 Thanking Joseph and our listeners for today’s episode! Contact Joseph at jsilvia@orielstat.com or on LinkedIn Oriel STAT A MATRIX: www.orielstat.com Reach out to us at solabs-podcast@solabs.com | |||
| Episode 46 - Defining Data Quality with Steve Gens | 10 Jan 2023 | 00:17:38 | |
Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today's episode features Steve Gens, Managing Partner at Gens & Associates. We will define data quality, what happens if the confidence in data quality is low, and provide some recommendations to keep it high.
Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021.
Key Takeaways 00:49 Introducing today’s guest: Steve Gens, here to discuss Data Quality with us 02:10 Defining Data Quality? 04:00 What happens when the confidence in the data quality is low? 05:48 Steve provides some recommendations related to Data Quality. 10:30 How does Data Quality bring Quality and Regulatory together? 13:26 what are some services Gens & Associates offer related to this topic? Reach out to us at solabs-podcast@solabs.com | |||
| Episode 45 - The World Class RIM Benchmark by Gens & Associates Featuring Steve Gens | 13 Dec 2022 | 00:22:36 | |
Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today's episode features Steve Gens, Managing Partner at Gens & Associates. We will discuss the World Class RIM Benchmark conducted by Gens & Associates, how it came into being, and some of its key findings over time.
Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021.
Key Takeaways 00:45 Introducing today’s topic: The World Class RIM Benchmark by Gens & Associates 01:15 Steve Gens’ Background 02:20 How did the World Class RIM come into being? 05:03 The origin of the RIM acronym 06:00 Steve shares some of the key findings of the benchmark over time 11:21 What does the industry need to get better? 13:10 Where does clinical stand compared to regulatory in terms of standardization 15:15 Is there a correlation between the ROI on new technology and having robust processes? 16:00 What has evolved over time in between those studies? 19:00 What would Steve recommend to students interested in the topic of RIM? 21:30 Thank you to our listeners! Contact us at solabs-podcast@solabs.com | |||
| Episode 44: Good Machine Learning Practices for the Medical Devices Industry with Ben Locwin | 01 Nov 2022 | 00:15:36 | |
Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.
The topic of today’s episode is good machine learning practices for the medical devices industry. Ben discusses some good machine learning practices (GMLP) and discusses the importance of standardizing those across the industry over time.
Key Takeaways 01:00 Today’s topic is good machine learning practices for the medical devices industry 01:20 Introducing today’s guest: Ben Locwin 03:30 Ben introduces good machine learning practice guiding principles 06:43 How quickly will there be a set standardized framework for good machine learning practices (GMLP)? 11:10 Why this topic matters a lot 12:15 Will new competencies need to be developed for understanding the regulations and techniques in the field of machine learning? 14:36 Thank you to our guests and listeners! | |||
| Episode 43: Artificial Intelligence and Machine Learning in the Medical Devices Industry with Ben Locwin | 04 Oct 2022 | 00:20:44 | |
Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.
Today’s topic of discussion is artificial intelligence and machine learning. Ben delivers some background on those buzzwords, how they relate to the FDA’s action plan, how this will impact the medical device industry moving forward, and more!
Key Takeaways 01:22 Introducing today’s guest Ben Locwin 03:26 Some background on artificial intelligence and machine learning 05:24 Common misunderstandings about those buzzwords 07:10 What is deep learning versus machine learning and AI? 08:43 How do these areas relate to the FDA’s action plan? 14:05 How will this impact the medical device industry moving forward? 18:40 Mandy thanks Ben for joining us on the show | |||
| Episode 42: Gens & Associates' Quality Benchmark with Katherine Yang-Iott | 06 Sep 2022 | 00:25:46 | |
Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! In today’s episode, we will discuss the discoveries of the Quality Benchmark conducted by Gens & Associates in late 2021. Our guest today is Katherine Yang-Iott. She is a consultant and analyst for Gens and Associates and the study lead for the firm’s first Quality-focused benchmark. She’s had 2 decades of experience as a scientist and researcher. Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021.
Key Takeaways 01:32 Introducing today’s guest: Katherine Yang-Iott, an Analyst at Gens & Associates 03:07 Katherine introduces Gens & Associates and the context of this study 06:07 What were the key findings of this survey? 08:50 What is a QMS in the perspective of Katherine 11:12 What was the goal of the study in terms of information produced? 14:20 How the pandemic has increased companies’ focus on supplier management 20:00 Mandy mentions that CAPA is a quality process that companies still struggle to get right today 21:20 Philippe shares his thoughts on the benchmark’s key learnings 22:57 What are the next steps for G&A in the world of quality? 25:15 Mandy thanks our guest and invites listeners to share their feedback | |||
| Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin | 02 Aug 2022 | 00:18:22 | |
Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.
The topic of today’s discussion is the Real-World Evidence framework as defined by the FDA. We highly recommend listening to the previous episode on Real-World Data and Real-World Evidence before diving into this one.
Key Takeaways 00:17 Mandy introduces Ben back to the show 01:13 Today’s topic is the Real-World Evidence framework 02:24 What is the FDA’s definition of Real-World Evidence? 06:50 What is being looked at for the framework? 09:16 What are the 4 Vs of data? 11:18 How do you define your hypotheses in advance when looking at data? 15:44 Mandy reflects on today’s discussion | |||
| Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia | 06 Aug 2024 | 00:15:12 | |
Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the second in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. In this episode, we discuss the definition of AIBOM, how it differs from SBOM, and take an educated guess at their future. Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely knowledgeable about the regulatory landscape, and we frequently refer to him for his regulatory expertise.
Key Takeaways; 01:05 Introducing guest Joseph Silvia 02:20 What is the concept of AIBOM? 04:23 Why AIBOM and SBOM should be separate discussions 07:45 How does open-source software impact those bills of material 11:22 How do you assess the risk of an AIBOM?
Contact us at solabs-podcast@solabs.com | |||
| Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin | 12 Jul 2022 | 00:22:01 | |
Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features a conversation with guest expert Ben Locwin. Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. The topic of today’s discussion is about defining what are Real-World Data and Real-World Evidence (RWD & RWE).
Key Takeaways 01:13 Introducing today’s guest: Ben Locwin 03:03 Philippe discusses the link between Real-World Data and its connection with technology 05:05 Ben defines Real-World Data and Real-World Evidence 10:28 Philippe discusses the importance of the integrity of data gathered from different sources 12:18 The importance of looking at the data with a specific hypothesis in mind 15:45 There is a lack of standardizing in data that leaves some concern 17:07 What is the FDA looking for regarding Real-World Data and Real-World evidence? 20:00 Ben shares his closing thoughts on the topic
Contact us at solabs-podcast@solabs.com | |||
| Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin | 07 Jul 2020 | 00:21:02 | |
Welcome to the 39th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
In today’s episode, Mandy Gervasio and Nathalie Bourgouin (the Vice President of Compliance at Skillpad), are continuing on the topic of clinical inspection readiness. This episode is the last in the four-part series. If you haven’t already tuned in to the previous three episodes, be sure to listen to those first before tuning into this one! In Part 1 Mandy and Nathalie discussed the Initiation phase, in Part 2 they discussed the Planning phase and in Part 3 they discussed Execution and Monitoring.
This week, they are discussing the Closing phase of clinical inspection readiness! Nathalie discusses the importance of the close-out meeting, provides guidelines for responding to the inspector’s observations and suggests tips for making a useful internal inspection report.
Key Takeaways:
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| Episode 38: Data Integrity and Data Governance in a Remote Work Environment with Ben Locwin | 09 Jun 2020 | 00:36:07 | |
Welcome to the 38th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! This week, they are discussing Data Integrity and Data Governance in today’s landscape. Ben explains the difference between data integrity and data governance, discusses the challenges of remote work during COVID-19 from a GxP perspective and breaks down some tips for companies to incorporate work from home in their company culture in a safe and efficient way!
Key Takeaways 0 :33 : Mandy introduces today’s co-host Philippe Gaudreau. 1:22 : Mandy introduces today’s guest, Ben Locwin. 2:15: Today’s topic is Data Integrity and Data Governance in today’s remote work culture. 3:02: Ben provides an overview of his background in Life Sciences. 9:15: Ben explains the difference between data integrity and data governance. 9:50: The guests discuss the unique challenges for handling work from home and COVID-19 from a GxP Data Integrity perspective? 11:57: Philippe details some of the dangers for data integrity with employees working from home and shares his opinion on the future of online security. 14:31: Ben stresses the importance of the Quality / Regulatory and IT / Security team members work hand in hand to ensure the integrity of data. 17:15: Ben discusses the delicate balance between ease of use and standardization of inputs and outputs within software. 20:14: The group discusses tips and tricks for remote workers to improve their efficiency. 23:39: Ben insists on the importance of having a routine on the human psyche. 26:10: Mandy insists on the importance of recording important meetings to keep track of information 27:28: Philippe gives some tips for companies to incorporate work from home in their company culture in the long term. 30:27: Mandy suggests reviewing data governance policies and ensuring that the team is comfortable with working from home. 31:55: Ben stresses the importance of having clear data governance policies in the future. 33:53: Mandy thanks Ben and Philippe and reflects on today’s learnings.
Mentioned in this episode | |||
| Episode 37: Clinical Inspection Readiness: the Execution and Monitoring Phase with Nathalie Bourgouin — Part 3 | 31 Mar 2020 | 00:17:19 | |
Welcome to the 37th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
In today’s episode, Mandy Gervasio and Nathalie Bourgouin (the Vice President of Compliance at Skillpad), are continuing last week’s topic on clinical inspection readiness. This episode is part three in the four-part series. If you haven’t already tuned in to the previous two episodes, be sure to listen to those first before tuning into this one! In episode one, Mandy and Nathalie discussed the initiation phase, and in episode two, they discussed the planning phase.
This week, they are discussing the execution and monitoring phase of clinical inspectional readiness! Nathalie gets into the details of the various considerations and different stages of this phase and breaks down some of the most important key aspects. This phase is all about what to do once the inspector actually arrives — so don’t miss out on learning more about this crucial step!
Key Takeaways: [:31] About today’s episode, the third part of the four-part series. [:45] Mandy recommends listening to the previous two episodes before tuning into this one. [1:00] Mandy welcomes Nathalie back on the podcast. [1:29] Mandy introduces the third phase: execute and monitor. [1:42] Mandy thanks Nathalie once again for joining the podcast! [2:08] Nathalie brings listeners up to speed on what was discussed in previous episodes. [2:34] Nathalie introduces the topic this week: the execution and monitoring phase. [3:04] Nathalie highlights the key tasks during the execution and monitoring phase. [4:43] Nathalie explains how to pull the necessary data together for the first task: gathering the known issues and the available intelligence. [6:11] Nathalie gives her advice regarding preparing a list of potential GCP issues. [7:44] The key documents that need to be prepared prior to the inspection. [10:56] Nathalie highlights some details regarding inspection expectations and shares what the day of the inspection will likely look like. [12:46] Nathalie gives best practice advice for making sure things move along as planned. [14:40] Nathalie provides further insight into monitoring progress and the identification of issues. [16:02] About the final episode in the four-part series covering the final phase: closing the inspection. [16:23] Mandy thanks Nathalie for sharing her insights in this episode and reiterates what the next and final episode in the series will be covering.
Mentioned in this Episode: | |||
| Episode 36: Clinical Inspection Readiness: the Planning Phase with Nathalie Bourgouin — Part 2 | 17 Mar 2020 | 00:25:31 | |
Welcome to the 36th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
On today’s episode of Automating Quality, Mandy Gervasio and Nathalie Bourgouin, the Vice President of Compliance at Skillpad, are continuing last week’s topic on clinical inspection readiness. This episode is part two in a four-part series.
In the previous episode, Mandy and Nathalie took a look at the initiation phase of GCP inspection readiness. This phased approach that Nathalie has put together has made it easy for listeners to synthesize this topic effectively.
Mandy and Nathalie know how technical and challenging it can be to maintain expertise in various areas. So, if you are fairly new to the life sciences industry this series will be incredibly beneficial in learning more about inspection readiness planning!
Be sure to tune in to the second part in this series as they focus on the planning phase of GCP inspection readiness and break down the key aspects.
Key Takeaways: [:32] About today’s episode, the second part in a four-part series. [2:43] Mandy welcomes Nathalie back on the podcast. [2:50] Nathalie brings listeners up to speed on what was previously discussed. [3:55] Nathalie explains the project planning phase that follows the initiation phase. [5:00] Nathalie details the three main tasks in the planning phase: preparing the plan, execution, and monitoring. [5:50] Nathalie explains the goals of the inspection readiness plan. [7:00] Nathalie walks listeners through the typical paths of actions that should be outlined in the readiness plan. [10:45] Nathalie provides additional tips on key actions to consider when preparing your team for the inspection. [13:21] Mandy emphasizes that it is normal and expected to refer to procedure during the audit. You are not required to know everything by heart! [14:07] Nathalie gives her recommendations on general guidelines for interacting with inspectors. [16:34] The do’s and don’ts when interacting with an inspector. [18:43] Nathalie’s #1 piece of advice for interacting with an inspector. [20:42] Mandy and Nathalie highlight the importance of knowing when to ask for help. [23:02] Nathalie explains the last task of the planning phase: monitoring the deliverables. [24:02] Mandy wraps up this week’s episode by thanking Nathalie, reflecting on today’s learnings, and announcing the next show in the series: the monitoring phase.
Mentioned in this Episode: | |||
| Episode 35: Clinical Inspection Readiness: the Initial Stage with Nathalie Bourgouin — Part 1 | 03 Mar 2020 | 00:20:14 | |
Welcome to the 35th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s show is pretty exciting! Mandy is going to be revisiting a topic that Automating Quality covered a bit last season around the GCP space. Joining her to discuss this topic is a veteran guest of the show who previously introduced the GCP topic — Nathalie Bourgouin! Nathalie is the Vice President of Compliance at Skillpad, which is a sister company of SOLABS. With nearly 30 years of experience in pharmaceuticals and biotech in North America and Europe, Nathalie is a leader in compliance, quality, and project management, with a solid background in risk-based quality assurance processes, training, and auditing. She has planned and audited many GMP and GCP vendors, as well as numerous clinical sites in local and global studies.
Nathalie is kicking off this episode as the first in a four-part series around GCP inspection readiness from a phased approach perspective. Each of the four episodes will take a look at inspection readiness from four different stages, with the first one being the ‘Initiation’ phase.
For those that have yet to be involved in an inspection or in inspection readiness planning, this episode will be especially beneficial!
Key Takeaways: [:33] Mandy introduces this episode’s topic. [1:18] Nathalie Bourgouin introduces herself and provides a background of her career. [2:29] Nathalie further explains the topic for today’s episode and the content the full four-part series will cover. [3:07] Nathalie explains what inspection readiness truly refers to. [5:04] What are the first steps you should take when a regulatory agency comes knocking at the door? [7:09] Nathalie further defines the Initiate stage and explains why it is so critical. [8:37] How is an inspection “confirmed”? [10:11] Nathalie breaks down the Initiation stage from a task perspective. [12:11] How does Nathalie identify the key players? What does the vetting process look like and how does she assign those roles? [13:26] How Nathalie ensures all team members are feeling ready and comfortable for the inspection. [15:43] Once the inspector has arrived, what should you expect? [17:12] Mandy wraps up the first episode in the four-part series!
Mentioned in this Episode: | |||
| Episode 34: Artificial Intelligence from a Life Sciences’ Perspective | 18 Feb 2020 | 00:23:36 | |
Welcome to the 34th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
In this week’s episode, Mandy Gervasio is bringing you a fascinating and timely topic to discuss: Artificial Intelligence or AI. This technical niche and hot industry trend of adoption is quite fascinating and you’ve probably been hearing this term a lot — especially in the last year or two!
She’s going to discuss the impact of AI on the life sciences industry as well as some considerations from a regulatory lens. She’s going to shed light on some of the key tools that are setting precedents in the industry as well as considerations from a regulatory compliance perspective.
Key Takeaways: [:38] About today’s episode: artificial intelligence from the life sciences’ perspective. [2:04] Mandy starts off the episode by defining the term artificial intelligence, or AI. [2:59] Mandy speaks about the research and development phase (or R&D phase) of a product development life cycle and the adoption they’re starting to see with regards to AI tools. [4:48] Mandy shares some examples of how AI technology is driving changes in life sciences and making significant impacts on public health. [6:07] Mandy discusses where she’s seeing more rapid adoption of AI technology and how it is driving positive change in the life sciences landscape, starting by focusing on the R&D phase. [10:06] Mandy highlights another key trend they’re seeing for AI deployment as it relates to clinical trial design. [11:09] Mandy discusses some key challenges that life sciences are faced with in light of this cutting-edge technology. [13:44] Mandy stresses the importance of developing and deploying a clear vision prior to adopting AI and other technological tools and business solutions. [14:33] Mandy continues to discuss some more of the key challenges that life sciences are faced with regards to AI technology. [18:32] Mandy summarizes her thoughts regarding AI adoption in the life sciences industry. [19:45] Mandy thanks listeners for tuning in and gives some of her final thoughts regarding AI.
Mentioned in this Episode: Automating Quality Ep. 32: “Major Trends in Automation for the Life Sciences Industry in 2020” | |||
| Episode 33: Case Study for Implementing an EQMS from a System Owner’s Lens | 04 Feb 2020 | 00:37:21 | |
Welcome to the 33rd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today, Mandy is joined by her co-host, the CEO and founder of SOLABS, Philippe Gaudreau, to bring you a bit of a different episode than usual! They’re going to be walking listeners through a case study that is incredibly relevant to their friends and partners in life sciences in terms of system ownership. These are the things that you may encounter and should consider as part of a case study related to implementing a new EQMS system from the system owner’s lens within the quality function.
Philippe will be playing the role of Mandy’s guest expert as well as the QA Director who will be owning this initiative in the case study. Together, Mandy and Philippe will be walking listeners through what they feel are some of the most important things that you’ll face if you have not yet engaged in this type of initiative.
Key Takeaways: [:33] Mandy Gervasio welcomes Philippe Gaudreau to the podcast and introduces today’s subject: a case study for implementing a new EQMS from the system owner’s perspective. [2:55] Mandy explains the roles that she and Philippe will be taking for the case study. [3:29] Mandy explains the case study format/situation they will be exploring in today’s episode. [6:06] Philippe starts by providing his first (of three) recommendations for beginning the implementation process. [7:00] Philippe highlights the areas and roles where you need different people in this process. [9:18] Philippe stresses the importance of having a steering committee involved. [10:07] Philippe continues explaining other important and key roles in this process. [12:36] Mandy highlights some other fantastic episodes related to today’s subject for listeners who want to dive deeper and learn more. [14:07] Philippe provides his second recommendation for the implementation process. [17:35] Philippe gives his final recommendation. [19:19] Mandy and Philippe both stress the importance of having a migration plan for data management. [23:26] Mandy poses a scenario to Philippe about integrating a new EQMS into their current ERP system. Philippe speaks about what some of the project risks could be, what to consider, and the general timeline. [26:54] Philippe recommends some best practices for organizations to adopt as part of this rollout. [32:00] Mandy gives some advice and further recommendations on episodes to check out after listening to today’s! [33:20] Mandy explains the importance of planning for failure as well as success. [34:52] Mandy thanks Philippe for providing his expert advice on this week’s podcast. [35:05] Philippe introduces the new Automating Quality LinkedIn community group. [36:10] Mandy thanks listeners for tuning in!
Mentioned in this Episode: Automating Quality Ep. 32: “Major Trends in Automation for the Life Sciences Industry in 2020” Automating Quality Ep. 29: “Data Migration and Data Integrity with Philippe Gaudreau” Automating Quality Ep. 12: “Validating a Cloud-Based Solution with Philippe Gaudreau” Automating Quality Ep. 1: “Change Management with Rachel Fountain” Automating Quality Ep. 5: “The Do’s and Don’ts of Change Management with Rachel Fountain” Automating Quality Ep. 14: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds” (Lisa Helmonds is also featured in episodes: 15, 17, 18, 19 & 20) Automating Quality Ep. 3: “Phase Appropriate Quality with Mary Senica” | |||
| Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020 | 21 Jan 2020 | 00:26:08 | |
Welcome to the 32nd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode is kicking off season 3! Mandy is joined by her co-host, the CEO and founder of SOLABS, Philippe Gaudreau. Together, they will be discussing some of the major trends in automation for the life sciences industry in 2020.
If you want to know about the upcoming hot topics and trends to be aware of and prepare for in order to stay current and competitive in this ever-changing business landscape, be sure to tune in! These hot trends will be sure to add value to your current and future roles in the space of life sciences.
Key Takeaways: [:25] About today’s episode! [1:13] Mandy thanks listeners for tuning in through seasons 1 and 2. [1:49] Philippe joins in to thank listeners as well, and speaks a bit about what to expect for today’s episode. [3:13] Hot topic areas that are increasing visibility and growth for the life sciences. [6:28] Mandy elaborates on the notion of data analytics. [7:33] Philippe shares his perspective on big data and data analytics and where it’s headed in terms of driving changes within life sciences. [11:41] The way technology is shifting in life sciences. [13:16] Progress in mobile med device apps and wearable tech. [14:50] Philippe’s thoughts on mobile med device apps and wearable tech. [17:54] What blockchain technology is and how it is entering the life sciences. [19:29] An upcoming hot trend (to be discussed in a future episode): serialization. [20:11] Wrapping up the show, Philippe gives some thoughts on another hot trend: single sign-on solutions. [24:35] Mandy wraps up the show and thanks listeners for tuning in as always!
Mentioned in this Episode: Automating Quality Ep. 21: “Michael de la Torre on GMP Inspection Analytics” Automating Quality Ep. 29: “Data Migration and Data Integrity with Philippe Gaudreau” | |||
| Episode 31: Guest Tribute Show: ‘Best of’ Moments from the Last Two Seasons! | 10 Dec 2019 | 00:27:45 | |
Welcome to the 31st episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! And today, she is joined by her co-host, Philippe Gaudreau, the founder and CEO of SOLABS.
Today’s show is dedicated to all the SOLABIAN friends who have tuned in for each episode and have supported Automating Quality’s journey for the past two seasons! Mandy and Philippe have been on this thought leadership mission for one and a half years now, partnering with life sciences subject matter experts to bring relevant industry trends and best practices to the forefront.
In this episode, they will be taking a look back at the last two seasons, highlighting some of the best clips from previous episodes. Mandy and Philippe have covered so many topics over the past two seasons — from automated system best practices such as validating your cloud solutions and maintaining data integrity, to various best practices areas like inspection readiness and global inspection trends; as well as current hot topics. For new listeners, this could be a great episode to tune into to find out which episodes you want to go back and listen to next!
So sit back, relax, and enjoy this episode dedicated to all of you — Automating Quality’s listeners!
Key Takeaways: [:32] Mandy opens up today’s episode by thanking guests and listeners for tuning in for the past two seasons! [1:54] Philippe thanks Mandy, the guests, and listeners of Automating Quality, and reminisces on their podcast journey. [3:23] About today’s special ‘best of’ episode! [4:42] In this first clip, Rachel Fountain speaks about implementing a change management process from episode 1. [5:29] Jay Turner speaks about optimizing compliance from episode 2. [5:55] In this episode 3 clip, Mary Senica speaks about evaluating and implementing a software solution. [6:38] Alan Greathouse speaks about measuring operational effectiveness from this episode 4 clip. [7:00] Rachel Fountain highlights some do’s and don’ts of change management from episode 5. [7:36] Rich Greer gives his thoughts on data integrity from this episode 6 clip. [8:21] In this episode 7 clip, Dr. Richard Prince explains the term ‘local-global’ and why it is so useful to remember. [9:14] Nathalie Bourgouin explains the main difference between a GMP quality system versus a GCP quality system from episode 8. [9:47] Graham O’Keefe gives his thoughts on effective training methods for millennials from episode 9. [10:26] Jay Turner speaks about social and collaborative learning from this episode 11 clip. [10:57] In this episode 12 clip, Brian McNamara speaks about building an effective training assessment program. [11:25] Philippe Gaudreau speaks about validating a cloud-based solution from episode 12. [12:20] In the first episode of the 6-part series (ep. 14), Lisa Helmonds gives her thoughts on some of the key elements of virtual life sciences company. [13:02] In episode 2/6 of the series (ep. 15) with Lisa, she speaks about some of the qualifications and oversight of contract service providers. [13:51] In episode 3/6 (ep. 17) of the series with Lisa, she speaks about quality agreements. [14:55] In episode 4/6 (ep. 18) of the series with Lisa, she gives her thoughts on quality culture. [15:37] In episode 5/6 (ep. 19) of the series with Lisa, she speaks about management review and quality metrics. [16:26] In the last episode of the series with Lisa (ep. 20), she speaks about investigation deviations and non-conformances. [17:01] In this episode 21 clip, Michael de la Torre speaks about GMP inspection analytics. [17:47] Justin Lacombe gives his thoughts on quality by design from episode 22. [18:50] Jay Turner speaks about what makes a good facilitator from episode 23. [19:28] Phil Becker speaks about leveraging a risk-based approach to develop, implement, and maintain your IT program from episode 25. [20:38] In this episode 27 clip, Kathy Landes speaks about the LIR process. [21:15] Mandy speaks about data migration from this episode 29 clip. [22:07] Nathalie Bourgouin speaks about inspection readiness from a GCP and GMP lens. [22:34] Mandy thanks listeners for tuning in to today’s episode and shares when Automating Quality will be returning for season 3!
Mentioned in this Episode: | |||
| Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia | 09 Jul 2024 | 00:16:36 | |
Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the first in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. We explore the history of SBOM, its current importance for the FDA, and how to ensure you have an SBOM in place when implementing or developing medical devices.
"Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely knowledgeable about the regulatory landscape, and we frequently refer to him for his regulatory expertise.
Key Takeaways 01:10 Introducing today’s guest: Joseph Silvia 02:35 What is an SBOM? 04:24 What is the history of SBOM? 05:50 Now, the government is getting involved and SBOM is picking up steam. 06;35 What is the FDA’s expectation on this topic for the medical devices industry? 09:03 When implementing or developing a device, how do you ensure that you have an SBOM in place to support it? 11:38 Who is responsible for SBOM within organizations? 14:37 Where can listeners learn more about this topic?
Reach Joseph at jsilvia@medwarecyber.com Contact us at solabs-podcast@solabs.com | |||
| Episode 30: Inspection Readiness from a GCP and GMP Lens with Nathalie Bourgouin | 26 Nov 2019 | 00:29:52 | |
Welcome to the 30th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode is all about inspection readiness and distinguishing what that looks like from both the GMP side and the GCP side. And joining Mandy today is return guest, Nathalie Bourgouin! Nathalie is the Vice-President of Compliance at Skillpad — a sister company of SOLABS — where she leads the Compliance Consulting Group, with a focus on clinical trials and research compliance. She’s a very well-rounded, highly experienced expert in the space with more than 25 years of experience in pharmaceuticals and biotech!
In this episode, Nathalie highlights the key concepts regarding GxP inspection readiness, compares the differences between GMP and GCP inspection readiness programs, explains how a company can better prepare for an inspection, and even highlights some of the issues she often sees coming up in inspections.
Whether you are new to the life sciences space or are a veteran with many years of experience, you will gain something of value in today’s episode!
Key Takeaways: [:28] About today’s episode! [2:35] Mandy welcomes Nathalie to the podcast! [2:46] Nathalie highlights key concepts regarding GxP inspection readiness. [4:14] Nathalie compares GMP vs. GCP inspection readiness programs. [5:05] How can a company get ready for an inspection? [7:59] Nathalie highlights some of the issues that she commonly sees coming up in GMP regulatory inspections. [12:42] How GCP inspections differ from GMP inspections as well as some of the key differences in the inspection process between the United States and Canada. [18:59] Nathalie provides some key tips for preparing for an inspection. [21:23] Nathalie’s tips for preparing individuals on your team for an inspection. [24:45] Nathalie stresses the importance of identifying who your key people will be for the inspection and training them on what they should and should not say. [27:50] Mandy thanks Nathalie for her input on the show and reflects on some of the key learnings.
Mentioned in this Episode: Automating Quality Ep. 8: “The Specificities of GCP Quality Systems with Nathalie Bourgouin” | |||
| Episode 29: Data Migration and Data Integrity with Philippe Gaudreau | 12 Nov 2019 | 00:33:04 | |
Welcome to the 29th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today is a really fun episode! Mandy is joined by her co-host, founder and CEO of SOLABS, Philippe Gaudreau. And they’re partnering together in this episode to discuss data migration as it relates to data integrity.
This topic has risen to the top in relevancy in the GMP world, so today, Mandy and Philippe will be highlighting some of the best practices and strategies to consider when implementing these key concepts into your organization!
Mandy explains the link between data migration and data integrity; defines the concept of data migration and the key phases that should be considered for inclusion when developing a migration strategy; and then, from a regulatory compliance perspective, highlights what must be considered with regards to data migration. Later on, Philippe explains what has changed in the data migration area over the years and suggests methods for creating efficient migration projects.
Key Takeaways: [:28] About today’s special episode! [2:50] Jumping right into it, Philippe first asks Mandy to describe the importance of data migration in the Life Sciences space and to define the key phases of data migration. [9:24] Mandy explains the link between data migration and data integrity. [13:29] From a regulatory compliance perspective, what must be considered with regards to data migration? [15:27] Philippe explains what has changed in the data migration area over the years from his perspective. [18:55] Philippe suggests methods to create efficient migration projects. [23:56] What are the international standards related to data migration? [26:18] What are some qualification approaches and strategies to ensure data integrity? [29:32] Mandy shares a personal experience with data migration processes. [30:23] Mandy wraps up this week’s episode and thanks Philippe for joining her today!
Mentioned in this Episode: | |||
| Episode 28: Regulatory Convergence and Its Impact on the Life Sciences Industry | 16 Oct 2019 | 00:13:57 | |
Welcome to the 28th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode is all about regulatory convergence! In the world of globalization, it makes sense that we’re finally starting to see extensive shifts in philosophy and regulations as they apply to the Life Sciences industry, which are setting new quality standards for drug and device manufacturers. It’s a very exciting topic as there have been some incredibly notable changes in the last 5 years!
In this episode, Mandy will be highlighting some of the key pieces to consider when thinking about the concept of regulatory convergence and explains how it is driving extensive shifts in the Life Sciences space.
Key Takeaways: [:28] About today’s episode. [1:00] Mandy explains what the term ‘regulatory convergence’ refers to. [2:38] What is the Mutual Recognition Agreement (MRA) and how is it related to the concept of regulatory convergence? [5:22] Mandy highlights some of the key benefits impacting public health that stem from regulatory harmonization. [8:25] Mandy speaks about the two major international standard bodies that are playing a vital role in regulatory harmonization (or convergence) and highlights the technical areas that they are affecting. [12:59] Mandy wraps up this week’s episode and thanks listeners for tuning in!
Mentioned in this Episode: | |||
| Episode 27: The LIR Process and Key Considerations for Robustness with Kathryn Landes | 02 Oct 2019 | 00:26:43 | |
Welcome to the 27th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today on the podcast, Mandy is bringing you a topic that has yet to be discussed in-depth on the show, and that is Laboratory Investigation Reports (also known as LIRs) and critical elements to consider when designing or implementing enhancements to the quality management process. Ensuring that your LIR process is robust is critical to your business operation and will help set you up for success if scrutinized during an inspection. All-in-all, it is a key part of the QMS.
Joining Mandy today is Life Sciences veteran and Quality expert, Kathy Landes, to provide expert feedback on this topic! Kathryn has more than 20 years of experience and is an absolute wealth of knowledge in this space! As someone who has spent many years developing and managing QC laboratories as part of her career as a quality professional and knows the LIR process inside and out, Kathy sheds light on some of the key areas to consider, breaks down some of the processes to their fundamental parts, and highlights many important considerations related to LIR.
Key Takeaways: [:30] About today’s episode. [1:22] Mandy welcomes Kathryn Landes to the podcast! [1:57] Kathryn gives an overview of her background in the Life Sciences space. [4:10] What is the intent of the LIR process? And what are the key elements that must be included as part of a robust process? [8:13] What are some common issues or barriers related to the LIR process that are often scrutinized by regulatory agencies? [14:27] Kathryn recommends some best practices for companies that are new to implementing this process as part of their QMS infrastructure as well as those who are focused on improving their existing process. [19:22] What steps should be taken when the root cause of an issue cannot be pinpointed through the LIR process? [23:50] Mandy recaps the key learnings from today’s podcast and thanks Kathryn for her time!
Mentioned in this Episode: | |||
| Episode 26: Current Hot Trends in the Medical Device Industry | 04 Sep 2019 | 00:16:52 | |
Welcome to the 26th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s show is focusing on a topic that has yet to be discussed on the show thus far, and that is the medical device industry and current hot trends from a regulatory perspective! Automating Quality has taken a look at regulatory trends from a broader perspective, but this is the first time they will be diving deep into the current happenings in the device space.
This episode will shed light on some key areas in FDA shift and focus; provide information on innovating trends that are transforming this niche; as well as changes to medical device regulations, setting new precedents that the industry is being held accountable for adopting.
Key Takeaways: [:29] About today’s episode! [1:20] Mandy explains how the FDA is using science to help innovate and accelerate the medical device industry, as well as why the FDA is so invested in pioneering enhancements to this specialized area of the life sciences industry. [3:30] The context of use on MDDT tools. [4:30] The types of categories that fall under the MDDT Program and how these categories are assessed. [7:55] Have new regulations been implemented that impact the medical device manufacturers? [10:52] Mandy explains some of the key impacts of these new regulations. [15:02] Mandy thanks listeners for tuning in! [16:10] If you have any questions or suggestions for future episodes, you can contact Mandy at Mandy.Podcast@Solabs.com.
Mentioned in this Episode: | |||
| Episode 25: How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil Becker | 06 Aug 2019 | 00:31:31 | |
Welcome to the 25th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode is all about leveraging a risk-based approach to develop, implement, and maintain your IT programs, extending to GxP controls and critical infrastructure. Guest industry expert, Phil Becker, will be joining Mandy today to discuss this topic and to provide guidance!
Phil has over 30 years of experience in the IT field. He’s an industry thought leader who’s held various strategic leadership roles, including Vice President of IT at Acculogix and Fisher Clinical Services, where he was Chief Architect and Developer of the first truly integrated 21 CFR part 11 compliant electronic batch record in the pharmaceutical supply industry. Phil has also developed the industry’s first web-based reporting software integrated solution. His vast experience in the space includes software application development, architecture, design for manufacturing, and regulatory compliance.
With Phil’s extensive background in the IT space and pharmaceutical arena, he will be providing some incredible guidance on what listeners should consider in terms of IT controls, which risk management tools and approaches you should be taking a look at, and other tactical considerations that will help with the developments and enhancements of your IT program and critical process controls.
Key Takeaways: [:35] About today’s episode. [1:50] Mandy welcomes Phil to the podcast! [2:49] How can a risk-based approach be leveraged to develop and implement an IT control strategy to support GxP business systems? [7:52] What are some risk management tools and approaches that are effective to assess the types of critical controls and the level of robustness that’s appropriate for business systems? [17:47] In regards to business continuity, what are some of the key inputs that should be considered for implementing and maintaining the business continuity program? And how can the effectiveness of these programs typically be assessed? [28:14] Mandy thanks Phil for joining her this episode! [30:30] Mandy thanks you all for tuning in for this week’s episode. If you want to get in touch with her, you can contact her at Mandy.Podcast@Solabs.com.
Mentioned in this Episode: | |||
| Episode 24: All About the Quality Risk Management Lifecycle | 09 Jul 2019 | 00:23:21 | |
Welcome to the 24th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s episode is focusing on quality risk management — the process for systematically identifying, assessing, and controlling risk to the quality of pharmaceutical products across the product lifecycle. Although the Automating Quality Podcast talks about risk quite often, this episode will be specifically zoning in on the concept of quality risk management (or QRM), how it is implemented, the four key phases that define the QRM lifecycle, and many other important additional elements. Mandy Gervasio will be breaking down this topic in today’s solo’s episode, highlighting the most foundational key elements of QRM!
Listeners that are new to the industry and veterans alike will get plenty of value from today’s episode. So be sure to tune in to brush up on the fundamentals of leveraging a QRM methodology!
Key Takeaways: [:30] About today’s episode. [1:35] What is QRM? And where is this methodology most often leveraged? [4:23] How is QRM implemented? And what are some key benefits? [5:26] How ICH Q9 has impacted the pharma industry, as well as transformed past precedences. [10:40] Mandy outlines the four key phases that define the QRM lifecycle. [14:31] Mandy highlights an important element to the QRM lifecycle: risk communication. [16:02] How ICH Q9 has been the catalyst for a significant paradigm shift in traditional GMP processes and benchmark standards. [20:05] Mandy wraps up the episode by summarizing what QRM is. [20:43] What to look forward to in future episodes! [21:09] Mandy thanks you all for tuning in for this week’s episode. If you want to get in touch with her, you can contact her at Mandy.Podcast@Solabs.com.
Mentioned in this Episode: | |||
| Episode 23: Innovation to Retrovation: Maintaining GTP in a GxP World, with Jay Turner | 25 Jun 2019 | 00:32:39 | |
Welcome to the 23rd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today, Mandy is joined by her co-host, Philippe Gaudreau, and return guest from episodes two and ten, Jay Turner! Jay is the CEO and founder of EduJay LLC., and he is a self-proclaimed learning and development ninja! He has devoted his career to improving people, processes, and programs to produce business results. This includes everything from implementing learning management systems, to designing staff development and leadership development programs, to providing executive coaching.
In this episode, Mandy and Jay are discussing innovation to retrovation — an interesting concept about maintaining GTP (AKA Good Training Practices) in a GxP world. Jay gives his expert feedback on the concepts of GTP, explains what he means by “retrovate” and how it applies to training, gives his top three favorite GTPs and how they can be leveraged in the quality space, and also explains how we can effectively innovate in training when we know it’s needed. The feedback that Jay provides in this episode will be incredibly beneficial for listeners who are considering enhancements to their current training and professional development programs. So tune in to get all of his valuable insight on today’s topic!
Key Takeaways: [:32] About today’s episode with return guest, Jay Turner! [2:37] Mandy welcomes Jay back to the show! [2:49] What does Jay mean by “retrovate” and how does it apply to training? [7:12] Jay lists his top two out of three GTPs and how they can be leveraged in the quality space. [14:20] Jay speaks about moving beyond required training and empowering staff members to become a part of the learning function in the organization. [17:50] Jay explains his third favorite GTP. [21:26] How can we effectively innovate in training when we know it’s needed? [28:07] Mandy thanks Jay for joining her this episode! [29:05] Jay gives a quick background about himself and his organization, EduJay. [31:24] Mandy wraps us this week’s episode by thanking listeners for tuning and giving a quick summary of today’s episode!
Mentioned in this Episode: Automating Quality Ep. 10: “Social and Collaborative Learning with Jay Turner” | |||
| Episode 22: Justin Lacombe on Quality by Design | 11 Jun 2019 | 00:26:33 | |
Welcome to the 22nd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Justin Lacombe. Justin has a depth of experience in pharmaceutical development and implementing methodologies founded in Quality by Design (QbD). He is a Chemical Engineer and got his PhD in Chemical Engineering from Rutgers University. He has been spending the past 12 years in the inhalation part of life sciences and pharmaceutical development. He has gotten involved in the area of QbD in the last 4-5 years to try and understand how they can better their development on their products at Experic, where he serves as Director of Pharmaceutical Development and Manufacturing Services.
Today they are going to be discussing Quality by Design — a really important and hot topic in pharmaceuticals! In the past decade, there has been rapid adoption of QbD on the pharmaceutical side of the life sciences industry. So tune in to learn all about what QbD is, what the overall process looks like, the phases and approach of a formalized QbD process from a pharmaceutical development perspective, the relationship between QbD and experimental design, how QbD can help design an effective product development plan, and much more.
Key Takeaways: [:14] About today’s episode. [1:49] About today’s featured guest, Justin Lacombe. [2:08] Justin introduces himself and gives some background about his career. [4:05] Justin explains what QbD is and what the overall process looks like. He then goes a bit deeper, explaining the phases and approach of a formalized QbD process from a pharmaceutical development perspective. [9:01] Justin explains the relationship between QbD and experimental design, and how this all ties into controlled strategy for manufacturing. [15:18] Justin outlines how critical quality attributes and QbD can help design an effective product development plan. [20:41] Why is QbD so critical for tech transfer? [23:23] Mandy highlights the benefits of QbD. [25:35] Thanks for listening to this week’s episode! If you have any questions for Mandy you can contact her at . If you have any questions for this week’s guest, Justin Lacombe, you can contact him on his LinkedIn page, linked below.
Mentioned in this Episode: | |||
| Episode 21: Michael de la Torre on GMP Inspection Analytics | 21 May 2019 | 00:26:02 | |
Welcome to the 21st episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Michael de la Torre. Michael is Chief Executive Officer of Govzilla — the leading platform for GxP inspection analytics. As a company, they are leveraging the power of Big Data and Machine Learning to make government data accessible, usable, and valuable to everyone who needs it.
As the life sciences industry continues to evolve, with regulatory compliance remaining a critical factor for success, inspection trends are a tool to help companies to develop and enhance their quality management systems. Additionally, being aware of these current trends is a key factor for developing a robust audit readiness program. If you or your industry colleagues are seeking a good tool to enhance your understanding of inspection trends, you do not want to miss this week’s episode!
Key Takeaways: [:29] About today’s episode. [1:20] Michael introduces himself, his expertise background, and his company, Govzilla. [3:29] Michael speaks about the most important recent FDA inspection and enforcement trends. [7:49] What are the top items cited by the FDA in human drugs? And have there been any changes in the last couple of years? [12:22] Michael speaks about changes in the inspection scope since the issuance of the data integrity guidance in 2018. [16:11] Michael’s take on Cloud-based solutions for the life sciences industry. [18:15] What impact has the FDA had on the market with their efforts on being more open and transparent with their inspections and enforcement data? [22:53] How Govzilla could be incredibly useful for your organization! [23:18] Mandy and Philippe thank Michael for joining them this episode. [25:02] How to get in touch with Michael de la Torre and Mandy Gervasio.
Mentioned in this Episode: | |||
| Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam | 04 Jun 2024 | 00:18:08 | |
Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This episode is the second in a series on Inspection Readiness featuring guest Caroline Guay-Adam! In this episode, we dive into tips and tricks for maintaining Inspection Readiness including first time right, the importance of the Inspection Manual, and more!
Caroline Guay-Adam has over 15 years of experience as a quality professional before joining Skillpad as a Senior Compliance Consultant. She has plenty to share on compliance and has recently been helping clients implement strategies for being and staying inspection-ready.
Key Takeaways 01:18 Introducing today’s guest, Caroline Guay-Adam. 02:46 The importance of verifying the effectiveness of corrective actions. 04:55 Focus on what the inspector will be interested in. 06:11 Update the documentation whenever there is a change. 08:48 Employees need to be continuously prepared for inspections. 11:58 You need to have a dedicated Inspection Manual. 16:25 What is the expectation in terms of control of the inspection readiness program?
Join us at solabs-podcast@solabs.com Reach out to Caroline at cguayadam@skillpadcompliance.com! | |||
| Episode 20: Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting | 07 May 2019 | 00:33:44 | |
Welcome to the 20th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
This week, Mandy is wrapping up the six-part series focused around quality culture, the virtual pharma environment, and supply chain management; with Lisa Helmonds, the Vice President of MWA Consulting. She is also joined by her co-host, Philippe Gaudreau, the CEO of Solabs.
In this week’s episode, they discuss investigation deviations and non-conformances. Lisa provides many excellent tips to keep in mind as you become familiar with the investigation and deviation management process. These tips will surely help listeners enhance their quality programs! This is a wealth of information for those new to the industry and veterans alike!
This episode officially wraps up the six-part series with Lisa Helmonds! Be sure to subscribe to the podcast for more great episodes on quality management.
Key Takeaways: [:22] About today’s episode. [1:22] Lisa Helmonds introduces herself and provides some background on her career. [2:40] About today’s topic: investigation deviations and non-conformances. [3:21] Why are investigations of deviations and non-conformances so important in the industry? [4:52] Are these investigations required by regulatory agencies or voluntary? [5:57] Is there a difference between a deviation and a non-conformance? [9:50] What is a root cause analysis? [10:12] Tools that can be used in the investigation and the root cause analysis process. [12:23] What do you do after the root cause is identified? [18:17] What a full investigation report entails. [22:46] What constitutes a well-written investigation report. [27:00] From an audit perspective, what do investigators looks for during inspection regarding deviations? [29:08] Mandy recommends further listening. [30:17] Mandy thanks Lisa for joining her for this six-part series. [31:41] Mandy recaps what the six-part series covered. [33:08] About next week’s episode. [33:14] If you have any questions, requests, or suggestions, you can contact Mandy Gervasio at Mandy.Podcast@Solabs.com. If you have any questions for Lisa Helmonds, you can contact her on LinkedIn.
Mentioned in this Episode: Determine the Root Cause: The Five Whys Fishbone Diagram for Root Cause Analysis Failure Mode and Effects Analysis (FMEA) Part 5: “Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting” Part 4: “Quality Culture with Lisa Helmonds from MWA Consulting” Part 3: “Quality Agreements with Lisa Helmonds from MWA Consulting” Part 2: “Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA Consulting” Part 1: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA Consulting”
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| Episode 19: Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting | 23 Apr 2019 | 00:24:39 | |
Welcome to the 19th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! This week, Mandy is bringing you the fifth part of the six-part series focused around quality culture, the virtual pharma environment, and supply chain management. As always, she is joined by her veteran guest of the series, Lisa Helmonds! Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry. Today, Mandy and Lisa will be discussing management review and quality metrics. Lisa explains what a management review is, the overall goal of it, what her recommendations are in terms of the type of quality metrics that should be reviewed during the meeting, and how it is important in sustaining a quality culture. Be sure to keep tuning in for future episodes to hear the last part in the series with Lisa Helmonds!
Key Takeaways: [:29] About today’s episode. [1:03] Lisa Helmonds introduces herself and gives some background on her career. [2:26] About today’s topic: management review and quality metrics. [2:42] What is management review? [3:56] Who typically attends a management review from the various functions in the organization? [5:18] What’s the overall goal of a management review? [8:23] Is a management review required or is it voluntary? [12:02] What Lisa would recommend in terms of the type of quality metrics that should be reviewed during this meeting. [15:53] How Lisa sees management review as important in sustaining a quality culture. [22:39] About the last part of the series! [23:46] If you have any questions, requests, or suggestions, you can contact Mandy Gervasio at Mandy.Podcast@Solabs.com. If you have any questions for Lisa Helmonds, you can contact her on LinkedIn. | |||
| Episode 18: Quality Culture with Lisa Helmonds from MWA Consulting | 26 Mar 2019 | 00:21:57 | |
Welcome to the 18th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Mandy is excited to bring you the fourth part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space! As a reminder, Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.
Today, Mandy and Lisa will be focusing on quality culture for this part in the series. Lisa defines quality culture, explains who is responsible for instilling a quality culture, how it is expressed, and most importantly, why it is so crucial to a company’s overall success.
Be sure to keep tuning in for future episodes to hear the last two parts in the series!
Key Takeaways: [:14] About today’s episode. [:49] Lisa gives a quick overview of her background in life sciences. [2:01] About episode 3 and where this episode will be headed. [3:15] Lisa defines quality culture. [5:19] Who is responsible for instilling a quality culture? [8:29] How is a quality culture expressed? [13:04] Why quality culture is important to a company’s overall success. [20:10] How to get a hold of Lisa if you have any questions or comments! [20:25] About next week’s topic.
Mentioned in this Episode: Part 3: “Quality Agreements with Lisa Helmonds from MWA Consulting” Part 2: “Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA Consulting” Part 1: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA Consulting” | |||
| Episode 17: Quality Agreements with Lisa Helmonds from MWA Consulting | 12 Mar 2019 | 00:27:44 | |
Welcome to the 17th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
This will be the third part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.
Today, Mandy and Lisa are discussing quality agreements for this third installment in the series. Lisa provides some great insight into quality agreements and why they’re such a critical part of compliance and the supplier quality function. She also shares some great tips for employing these agreements in your own organizations and key things to consider in the process.
Be sure to keep tuning in for future episodes to hear the next three parts in the series!
Key Takeaways: [:33] About today’s episode. [1:20] Lisa talks about her experience in the life sciences space. [3:28] What is a quality agreement? And why is it needed? [5:09] What information should a quality agreement contain? [6:44] Some of the main advantages of executing a quality agreement. [9:03] How a quality agreement is different from a technical or commercial master service agreement. [20:05] How often should quality agreements be reviewed and revised? [23:35] Lisa and Mandy close out this week’s podcast! Be sure to continue to tune in for the next three parts of the series! If you have any questions or requests for the show, email Mandy at Mandy.Podcast@Solabs.com. If you have any questions for Lisa, contact her on her LinkedIn.
Mentioned in this Episode: Part 2: “Qualifications and Oversight of Contract Service Providers with Lisa Helmonds” Part 1: “Key Elements of Virtual Life Sciences Companies with Lisa Helmonds” | |||
| Episode 16: Continuous Improvement of Quality Management Systems | 26 Feb 2019 | 00:12:42 | |
Welcome to the 16th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
In this week’s episode, Mandy dives deep into the topic of continuous improvement of quality management systems. She discusses what is meant by continuous quality improvement, the expectations from a regulatory perspective, key systems that are leveraged to provide visibility and enhance quality throughout an organization, why quality management review is important in terms of your quality infrastructure, and types of external factors that can influence a company’s need to continuously improve.
Key Takeaways: [:14] About today’s episode. [:51] What is meant by continuous quality improvement, and what are the expectations from a regulatory perspective? [2:42] Key systems that are leveraged to provide visibility and enhance quality throughout an organizations. [3:58] Why quality management review is important in terms of your quality infrastructure. [5:53] What types of external factors can influence a company’s need to continuously improve? [11:11] Thank you for joining Mandy on this week’s podcast, and be sure to join her in two weeks for a follow-up episode on quality agreements with Lisa Helmonds.
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| Episode 15: Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA consulting | 12 Feb 2019 | 00:22:11 | |
Welcome to episode 2 of the 6-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.
Last week’s episode focused on the details of what a virtual company looks like, and the unique advantages and challenges to consider in the virtual framework. In this week’s episode, Lisa, Philippe, and Mandy are diving even deeper into the topic, and discussing qualifications and oversight of contract service providers.
Be sure to keep tuning in for future episodes to hear the next four parts in the series!
Key Takeaways: [:24] About today’s episode. [1:25] Lisa describes the topic for this week’s episode and talks a bit about her background in life sciences. [3:24] Why is the qualification of contract service providers important to managing quality? [6:21] What qualification of a contract service provider entails. [11:06] Tools that are available to determine which contract service providers should be audited along with the frequency of those audits. [15:15] What responsibility does a sponsor have with regard to contract service provider oversight? [20:53] About the third episode in the six-part series.
Mentioned in this Episode: ICH.org - Q7 Good Manufacturing Practice Guide ICH.org - Q8 Pharmaceutical Development ICH.org - Q9 Quality Risk Management ICH.org - Q10 Pharmaceutical Quality System Failure Mode and Effects Analysis (FMEA) Failure Mode, Effects, and Criticality Analysis (FMECA) Hazard Analysis and Critical Control Point (HACCP) Hazard and Operability Study (HAZOP) | |||
| Episode 14: Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA consulting | 29 Jan 2019 | 00:26:32 | |
Welcome to the first episode back in the new year! Your host, Mandy Gervasio, and her co-host, Philippe Gaudreau, the CEO of Solabs, are back to start a very interesting new series.
Continuing their mission to bring more clarity around the world of quality and automation in the area of life sciences, they’ve invited on a life sciences expert, Lisa Helmonds. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical and medical device industries. She has extensive GXP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry.
This new series is the first of six parts about virtual companies in the life sciences space. In this particular episode, Lisa digs into the details of what a virtual company looks like and the unique advantages and challenges to consider in the virtual framework.
Be sure to keep tuning in for future episodes to hear the next five parts in this series!
Key Takeaways: [:31] About today’s episode. [1:22] More about today’s episode (the first part of a six-part series!) and today’s guest, Lisa Helmonds. [1:55] Lisa introduces herself and talks about her background and current role at MWA Consulting. [3:38] How Lisa defines a virtual company. [5:47] Some of the advantages of being a virtual company. [7:40] On the flipside, some of the disadvantages of being a virtual company. [12:35] The biggest risks of not managing quality. [17:00] Lisa outlines approaches to successfully managing quality at contract service providers, and key strategies and elements that would allow a virtual company to feel confident that quality is built into these partnerships. [23:42] Lisa gives a preview of the next segment in this series. [25:42] If you have any questions for this week’s guest expert, Lisa Helmonds, please contact her on LinkedIn. If you have any requests for the show or for Mandy Gervasio, you can contact her at Mandy.Podcast@Solabs.com.
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| Episode 13: Recapping Industry Trends in 2018 | 11 Dec 2018 | 00:14:20 | |
Welcome to the 13th episode of Automating Quality, the show that bridges the gap between automation and your quality management systems. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Being the last episode of the year, Mandy is bringing you a recap of the greatest industry trends in 2018 and taking a look back at the last 12 episodes of Automating Quality. She’s reviewing some of the key highlights, including: change management, operational effectiveness, phase appropriate quality, philosophies of quality, SAS validation, GCP quality, and data integrity. Mandy also gives a summary of key topics around advancement and regulatory trends of this past year.
Join her this episode for a walk down memory lane!
Key Takeaways: [:30] About today’s show! [1:14] Mandy’s first highlight: change management. [2:50] Key highlights from AQ’s episode on operational effectiveness. [3:13] Another key topic: phase appropriate quality. [3:50] Highlights from the ‘philosophy of quality’ episode. [5:33] About Mandy and Philippe’s episode on SAS validation and GCP quality. [7:35] Mandy discusses another important trend: data integrity. [8:31] Mandy gives thanks to listeners for tuning into AQ these past six months. [9:07] If you have any comments or suggestions for future episodes of AQ, feel free to reach out to Mandy at Mandy.Podcast@Solabs.com or on her LinkedIn. [9:33] Mandy gives a summary of key topics (around advancement and regulatory trends) that took place in the industry, in 2018. [12:35] Mandy wraps up this week’s episode and wishes all listeners a happy 2018.
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| Episode 12: Validating a Cloud-based Solution with Philippe Gaudreau | 27 Nov 2018 | 00:24:51 | |
Welcome to the twelfth episode of Automating Quality, the show that bridges the gap between automation and your quality management systems. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
Today’s show is focusing on validating a Cloud-based solution. And the featured guest expert is none other than Mandy’s co-host, Philippe Gaudreau, the CEO of Solabs. Philippe has been in the technology industry for the past 20 years mostly within life sciences. He also has developed important competencies in computer system validation.
In this episode, Philippe discusses some critical aspects in regards to validating a GxP Cloud-based solution. He answers some valuable questions related to validation approaches and provides some great insight on how to streamline these approaches. This episode will definitely be of value to those in life sciences and related industries!
Key Takeaways: [:15] About today’s show and guest! [:37] Philippe talks about his background and more about today’s episode. [3:02] How has the utilization of GxP Cloud-based solutions by life sciences impacted software development companies? [8:25] Factors that should be considered that likely increase a life sciences client’s confidence in their SAS vendor as a partner. [13:36] How leveraging a risk methodology can influence a life sciences client’s approach to validation for a GxP SAS solution. Philippe gives his key insights to leveraging risk, that could be implemented to streamline and rightsize the validation effort. [22:03] Wrapping up this week’s episode!
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| Episode 11: How to Build an Effective Training Assessment Program with Brian McNamara | 13 Nov 2018 | 00:30:07 | |
Welcome to the eleventh episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Mandy is joined by her co-host, Philippe Gaudreau, and very special guest: Brian McNamara, the Marketing Director for Questionmark.
Today’s topic of discussion is building an effective training assessment program. Brian has a ton of experience in this niche and has some very good expert feedback on the topic. He really knows his stuff when it comes to electronic assessment and certifications!
Brian has been with Questionmark since 2004 and has an overall 20 years experience working with organization’s assessment technology providers. And Questionmark itself has been partnering with Solabs for over 10 years and have recently formalized their partnership even more through the QM 10 release. Their specialty is to provide assessment solutions that help organizations measure knowledge, skills, abilities, and attitudes — done in the areas of certification, as part of training, and regulatory compliance.
Key Takeaways: [:30] About today’s topic and guest. [2:29] Mandy welcomes Brian to the podcast. [2:52] Brian introduces himself and gives a quick background on Questionmark. [6:46] How are regulated life sciences clients currently using assessments? [11:55] Brian outlines key elements that companies should consider when designing an assessment program. [22:35] What Brian loves about operational assessment. [23:45] Mandy reflects on the last few years and the new-found emphasis on training, as well as some of the key takeaways of this week’s episode. [27:33] Brian’s thoughts on how far assessments have come and their goals at Questionmark. [28:31] What to look forward to in a future episode! [28:58] A thank you to listeners and a summarization of this week’s episode. [29:21] If you have any questions or requests, contact Mandy at Mandy.Podcast@Solabs.com . If you have any questions for Brian McNamara, you can reach him on his LinkedIn.
Mentioned in this Episode: | |||
| Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam | 07 May 2024 | 00:15:19 | |
Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quality professionals: inspection readiness! Our guest Caroline Guay-Adam discusses inspection readiness and how to reach and maintain an inspection-ready state over time. Caroline Guay-Adam has over 15 years of experience as a quality professional before joining Skillpad as a Senior Compliance Consultant. She has plenty to share on compliance and has recently been helping clients implement strategies for being and staying inspection-ready.
Key Takeaways: 00:42 Introducing today’s guest: Caroline Guay-Adams 03:23 Why is inspection readiness necessary for Life Sciences companies? 05:24 How do you establish a strategy to be and stay inspection-ready? 08:00 What are the requirements for a company to call itself inspection-ready? 13:00 Which mindset is necessary for this strategy to remain successful over time? | |||
| Episode 10: Social and Collaborative Learning with Jay Turner | 29 Oct 2018 | 00:43:03 | |
Welcome to the tenth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today, Mandy is joined by her co-host, Philippe Gaudreau, and return guest from episode two, Jay Turner!
Jay is the CEO and founder of EduJay LLC. Jay is a self-proclaimed learning and development ninja at his latest entrepreneurial venture, EduJay! He has devoted his career to improving people, processes, and programs to produce business results — everything from implementing learning management systems, to designing staff development and leadership development programs, to providing executive coaching.
In this episode, Mandy asks Jay a handful of key questions that learning and development listeners will especially appreciate! He explains some of the key benefits of social and collaborative learning platform communities, some examples of technology platforms that could be implemented in a workplace to help drive engagement more efficiently, potential hurdles or barriers that might be posed by the GxP industry if leveraging ELOs, and more! Tune in!
Key Takeaways: [:40] About today’s episode and return guest, Jay Turner. [2:45] Jay introduces himself and explains his current mission with EduJay. [6:16] Jay explains some of the key benefits of social and collaborative learning platform communities. [13:35] Some examples of technology platforms that Jay thinks could be implemented in a workplace to help drive engagement more. [20:22] In Jay’s experience, does he think that employee engagement increases when leveraging social learning tools? [28:40] In Jay’s experience (in non-GxP industries) is the incorporation of external learning objects (or ELOs) a common practice? [32:30] What Jay sees as potential hurdles or barriers that might be posed by the GxP industry if leveraging ELOs. [37:23] Jay’s ideas on how to bridge the gap between GxP industries and leveraging ELOs.
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| Episode 9: Effective Training Methods for Millenials with Graham O’Keeffe | 15 Oct 2018 | 00:26:58 | |
Welcome to the ninth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau, as well as their guest for today: Graham O’Keeffe.
Graham O’Keeffe is the CEO of Learn About GMP. He has been in marketing and life sciences for about 20 years and has served roles in various pharmaceutical and biotech companies, focusing mainly on compliance, quality, registry, and quality systems. Learn About GMP is an online web-based training system platform that is designed specifically for life sciences companies. They provide knowledge and expertise that empowers these companies in accelerating their growth and maintaining compliance.
This episode is filled with helpful takeaways and key learnings for better organization and planning when it comes to developing training programs. Graham explains how continuous access to on-demand, web-based training with constantly-updating fresh content can greatly enhance a learner’s interest for learning and development. He also shares his perspective on the best content delivery methods to drive effectiveness for millennials; why continuous education is crucial to attracting top millennial workers; and how he sees the industry evolving over the next 3-5 years in terms of learning and development, content delivery, and mechanisms for enhancing compliance.
Key Takeaways: [:42] About today’s topic and guest. [1:45] Mandy and Philippe welcome Graham to the podcast. [2:26] Graham’s background and current mission of his company, Learn About GMP. [5:10] What are a few elements to consider for learning retention and effectiveness when tailoring training for a millennial audience? [10:30] Does Graham think that continuous access to on-demand, web-based training greatly enhances the learner’s interest for learning and development? [15:25] What content delivery methods Graham thinks should be commonly leveraged to drive effectiveness for millennials. [19:14] Why continuous education is crucial to attracting top millennial workers. [21:35] How Graham sees the industry evolving over the next 3-5 years in terms of learning and development, content delivery, and mechanisms for enhancing compliance. [25:11] Mandy wraps up this week’s episode and gives a quick summary of the key learnings. [26:08] About next week’s episode. [26:18] How to get in touch with Mandy and Graham O’Keefe.
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| Episode 8: The Specificities of GCP Quality Systems with Nathalie Bourgouin | 01 Oct 2018 | 00:22:10 | |
Welcome to the eighth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau. The focus of this week’s show is the specificities of GCP quality systems. Mandy and Philippe are joined by special guest, Nahtalie Bourgouin, VP of Compliance at Skillpad. Skillpad is a sister company of Solabs and Philippe has had the pleasure of collaborating with Nathalie over the years. With more than 25 years of experience in pharmaceuticals and biotech in North America and Europe, Nathalie is a leader in compliance, quality, and project management, with a solid background in risk-based quality assurance processes, training, and auditing. She has planned and audited many GMP and GCP vendors, as well as numerous clinical sites in local and global studies. The conversation with Nathalie today will surely help companies improve their quality levels. Some key topics discussed today include: the difference between GMP and GCP quality systems, how Nathalie has seen the global regulatory landscape change, the key variables to consider with GCP event management, and specific tools that can be utilized to help streamline the process.
Key Takeaways: [:34] About today’s topic and guest. [1:45] Nathalie introduces herself and talks about her background in quality and compliance. [3:30] How are the GMP and GCP quality systems different? And what are the idiosyncrasies of a GCP system? [5:17] How has Nathalie seen the global regulatory landscape change? And is this driving a new approach for managing clinical event occurrence? [7:20] What Nathalie sees as a few key variables to consider (as related to GCP event management). [9:34] Nathalie explains the type of approach that can be implemented to enhance the traceability and robustness related to clinical events that occur in the field. [13:04] Are there any specific tools that can be utilized to help streamline the process? [15:53] How does Nathalie see this approach, relating to the new ICH E6 guidance, in regard to data integrity? [21:18] How to get in touch with Nathalie or Mandy. [21:54] About next week’s episode.
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| Episode 7: The Philosophy of Quality with Dr. Richard Prince | 17 Sep 2018 | 01:03:57 | |
Welcome to the seventh episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends, and to provide awareness and tactical guidance to help strategically facilitate change.
In this episode, Mandy and Richard dive deep into what it means to build a quality-centric culture, as well as the potential impacts of not having those fundamental quality threads built into your infrastructure. They discuss how to become successful in a regulated company from a quality perspective, the fundamental building blocks of quality, compliance trends in the industry from the last annual FDA report, how to properly respond to an FDA observation, and Richard’s first principles of building a company culture of quality.
Key Takeaways: [:51] About today’s topic and guest. [1:49] About Dr. Richard Prince’s current mission with his company. [3:47] Richard gives an introduction to today’s topic. [4:38] How does one go about becoming successful in a regulated company in the pharmaceutical industry from a quality perspective? Richard explains his five-step algorithm that will ensure that you have a higher likelihood of being successful the first time around. [5:32] Richard explains the first of the five building blocks of quality: Knowledge and know-how. [7:02] The second building block of quality: Design verification. [8:03] About the third: Process Fidelity and transparency. [9:55] About the fourth: Performance metrics. [10:33] About the fifth and last building block: Rational decision making. [11:33] Richard reveals what’s remarkable about the compliance trends in the industry from the last, annual FDA report. [18:09] Mandy’s experience and thoughts on FDA warning letters and observations. [21:03] Richard emphasizes how to properly respond to an observation (from the FDA.) [21:53] Drug compliance issues and what the FDA cited them for (in the pharmaceutical industry). [24:21] Richard outlines the categories of compliance and enforcement actions that the FDA promulgates, what the 483 observation from the FDA is (and how to respond to it). [31:03] Richards reads what activities the FDA may consider warranting criminal prosecution. [33:16] Richard reviews some of the First Principles (7 out of 14) that are designed to help build a company culture of quality. [43:36] Mandy’s take on the First Principles. [46:03] Richard speaks about what makes some of the most successful companies and quality professionals. [47:14] Richard discusses the 8th First Principle: the importance of an independent quality unit. [48:17] Richard explains why courage is an important attribute. [50:12] Richard goes over the 9th First Principle: Establish suitability of equipment, facilities, utilities and methods. [50:48] Richard speaks about the 10th, 11th, and 12th First Principles: deploying risk assessment, understanding sources of variability and signals of drift, and understanding the link between safety, efficacy, and quality. [53:02] Richard explains the 13th and 14th First Principles: Quality is never static and requires continual improvement, and take quality and management action when necessary. [54:40] Richard reads a couple quotes that really help illustrate the importance of quality. [56:09] Richard summarizes the characteristics that successful quality systems possess. [1:00:18] Where to reach Richard and learn more about his company, Now Biopharma, LLC. [1:02:45] About next week’s episode, how to reach Mandy, and how to contact Richard.
Want a More Immersive Podcast Experience? Download Richard's Powerpoint Presentation to follow along!
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