Automating Quality – Détails, épisodes et analyse

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

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

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

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

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!

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

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

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

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!

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