Explore every episode of the podcast The Qualitalks Podcast

Imagine missing a critical air‑handler failure because your BMS drowns you in 1,400 daily alarms—Stephen Tierney, President of Xiltrix, reveals how an independent EMS can turn blind spots into compliance‑savvy insights for pharma, biotech, and med‑tech. Yan Kugel then explores real‑world sensor placement, AI‑driven pattern detection, and the human‑in‑the‑loop strategy that lets quality leaders prevent costly downtime.

-----------------------------------------------------------

This episode is supported by XiltriX . They provide 24/7 live agent monitoring for biotech and biopharma labs and facilities that need to prevent sample loss and maintain compliance

----------------------------------------------------------

--------------------------------------------------------------------Connect with us:☑ Podcast: https://podcast.qualistery.com☑ Facebook: https://www.facebook.com/Qualistery/☑ LinkedIn: https://www.linkedin.com/company/68350215☑ Twitter: https://twitter.com/qualistery

Visit ⁠⁠www.qualistery.com⁠⁠ for live free webinars for GxP professionals, to stay on top of the latest industry trends.

Imagine unlocking 20 years of QC data to let AI forecast instrument downtime. John Welsh of Agilent reveals how the Allotrope simplified model and modern lab informatics turn compliance into a competitive edge. Discover why regulated pharma, biotech and med‑tech leaders can’t afford to ignore this shift.

-------------------------

Episode Sponsor: Agilent is a global leader in life sciences, diagnostics and applied markets, recognized for uncompromising integrity in all we do. Our mission is to advance quality of life by focusing our expertise in six key markets: Food, Environmental and Forensics, Pharmaceutical, Diagnostics, Chemical and Advanced Materials and Research.

-------------------------

Want to stay current with the latest GxP trends? Join our free, enlightening certification webinars at ⁠⁠www.qualistery.com⁠⁠.

-------------------------

For guest or sponsorship inquiries, contact us at info@qualistery.com.-------------------------

In this episode, Yan Kugel and Konrad Sägesser discuss the latest trends and practical solutions in pharmaceutical water quality monitoring. Learn how continuous analytics, compliance, sustainability, and AI are reshaping water management in pharma manufacturing.Konrad is a Key Account Manager at Swan Analytical Instruments. He is a subject matter expert and co-author of the A3P Guidelines, alongside industry experts from Sanofi, BWT, and Veolia.

Can a single click replace years of tech transfer paperwork? Nikki Bishop, VP of Marketing & Experience at Emerson , reveals how AI‑driven digitization could slash delays for pharma, biotech, med‑tech, and other regulated manufacturers.

-------------------------

Episode Sponsor: Emerson is a global leader in automation technology and industrial software, providing innovative solutions that help life sciences manufacturers optimize operations, enhance efficiency, and ensure regulatory compliance. With a focus on digital transformation, Emerson enables smarter, data-driven decision-making to drive productivity, quality, and sustainable growth in highly regulated industries.

-------------------------

Want to stay current with the latest GxP trends? Join our free, enlightening certification webinars at ⁠www.qualistery.com⁠.

-------------------------

For guest or sponsorship inquiries, contact us at info@qualistery.com.-------------------------

Can custom active‑packaging technology add three years to a drug’s shelf life?

Badre E. Hammond, Global VP of Aptar Active Material Science, reveals how early‑stage material science can slash development time, meet FDA/EMA requirements, and neutralize nitrosamine risks for pharma, biotech, and med‑tech leaders.

Episode sponsor: Aptar Active Material Science is a premier active material science solutions expert that transforms ideas into market opportunities, accelerates and de-risks the product development process.

-------------------------

Want to stay current with the latest GxP trends? Join our free, enlightening certification webinars at www.qualistery.com.

Process Analytical Technology (PAT) has evolved from a niche troubleshooting tool into a strategic necessity—but most companies still implement it too late. 

Dr. Stanislav Kazakov from Thermo Fisher Scientific reveals why starting PAT early can mean the difference between scaling success and costly manufacturing failures.

Discover how real-time process insights, AI-driven chemometrics, and strategic implementation are reshaping quality control from lab to commercial scale across pharma and biotech.

----------------------

This episode is supported by Thermo Fisher Scientific.

partners across the drug lifecycle to accelerate discovery, scale manufacturing, and ensure compliant release. Our analytical and process technologies support pharmaceutical and biotech teams from research and formulation through commercial manufacturing and quality control. With integrated instrumentation, workflow solutions, and expert service, we help protect yield, ensure data integrity, and deliver therapies to patients with confidence.

----------------------Visit ⁠www.qualistery.com⁠ for live free webinars for GxP professionals, to stay on top of the latest industry trends.

What does it take to keep pharma & biotech CDMOs inspection‑ready across global sites? Senior VP of Global Quality, Melanie Kearney, reveals how she transforms quality culture, bridges R&D and manufacturing, and turns audits into a competitive advantage.

The episode is supported by OXB. 
OXB is a quality and innovation-led viral vector CDMO, supporting its clients in delivering their life-changing therapies to patients around the world.

--------------------------------------------

Visit www.qualistery.com for live free webinars for GxP professionals, to stay on top of the latest industry trends.

Yan Kugel is joined by Elizabeth Hickman, the CEO at AustinPx. With over a decade of experience in the biotech and pharmaceutical sectors, Elizabeth shares her insights on drug development, innovative manufacturing solutions, and the pressing need for sustainability in pharma.

In this episode, Yan Kugel is joined by Will Moss founder and CEO of Seal, about the critical need for automation in GXP processes. Will shares his expertise on balancing automation with human oversight, addressing data privacy concerns, and the future of quality management in the pharmaceutical sector.

In this episode, Yan Kugel is joined by Christy Mazzarisi, a distinguished leader in the pharmaceutical industry with extensive experience in quality systems and leadership roles. In this episode, we explore Christy's journey in pharma, her works, her impact on advocacy and leadership, and her vision for empowering women in the pharmaceutical industry.

In this episode, Yan Kugel is joined by Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse industries with finesse. She's the founder of the QneUp, a data-driven software tool that reduces equipment downtime and boosts productivity in the pharmaceutical industry. In this episode, we will be discussing data and FDA warning letters trends across the years with Simone.

In this episode, Yan Kugel is joined by Ben Coverdale, PhD, a seasoned global account director at Patsnap with a strong background in the life sciences and innovation and intelligence sectors. Ben brings a wealth of experience and insights into how AI and LLMs (Large Language Models) are transforming patent research and analysis in the pharmaceutical industry.

Yan Kugel is joined by Pavan Pasupulati, the Vice President of Manufacturing Excellence at Caliber Technologies.

Here, he shares valuable insights into the future of pharmaceutical manufacturing. With over 25 years of experience in both the process and IT industries, Pavan has become a key figure in driving digital transformation within pharmaceutical manufacturing.

Yan Kugel is joined by Vincent F. Cafiso⁠, the Director of Quality and Regulatory Services at CREO Consultancy and a former FDA investigator. Vincent shares invaluable advice on things never to say to an FDA investigator based on his extensive experience and expertise in the field. Join us as we uncover essential strategies and best practices to navigate FDA inspections with professionalism, compliance, and a proactive mindset.

In this episode, Yan Kugel is joined by Mohamed Amer, a seasoned executive with over 20 years of experience in strategic and commercial leadership in the healthcare industry. Mohamed emphasizes the significance of CME (Continuing Medical Education) accreditation when promoting pharmaceutical products. He further discusses the challenges companies face in different countries regarding ethical standards and regulations when promoting pharmaceutical products.

In this episode we are joined by Kelly Stanton, the Head of Quality Systems Improvement at Corden Pharma. Kelly discusses her transition back to the pharmaceutical industry after four years at Qualio, an eQMS provider. She also shares her improvement projects that make a real difference in her organization. Additionally, she shares insights on improving processes, the importance of regulatory compliance, and the impact of implementing changes within an organization. The conversation also delves into the benefits of using automated tools, making processes lean, and the significance of leveraging electronic tools to improve efficiency. Tune in to gain valuable insights into the pharmaceutical industry and the importance of continuous improvement in processes.

Yan Kugel⁠ is joined by Nagesh Nama, CEO at xLM who brings a wealth of experience and expertise in incorporating AI into validated processes within the pharmaceutical industry. Nagesh shares insights on the benefit challenges and best practices of using AI and machine learning technologies in pharmaceutical manufacturing quality. His insights shed light on the challenges and solutions in implementing AI in pharmaceutical manufacturing quality. The potential for AI to improve efficiency, reduce costs, and enhance regulatory compliance is evident, and the future of AI in pharma looks promising.

Yan Kugel⁠ is joined by Lesley Worthington, a communication and leadership coach for quality professionals. Together, they discussed the significance of interpersonal skills in the realm of quality assurance within the pharmaceutical industry. Lesley emphasizes that communication and interpersonal skills are often overlooked but are crucial for quality professionals. Technical knowledge is important, but it must be balanced with strong interpersonal skills to excel in the quality assurance field.

In this episode, we will delve into the future of pharma and explore the intersection of AI, ML, and GMP compliance. Today, we are thrilled to have Vasyl Chumachenko, head of AI consulting at Data Science UA, join us as our esteemed guest. With a wealth of experience in integrating AI solutions into chemical and pharmaceuticals, Vasil brings a unique perspective on driving innovation and growth in the industry.

In today's episode, our guest is Vivek Gera, the CEO of Leucine and a seasoned process engineer. Vivek has a wealth of experience leveraging cutting-edge technologies to enhance compliance and operational efficiency within pharmaceutical manufacturing. Throughout this episode, we will delve into the transformative impact of AI on manufacturing, QA, and QC processes, shedding light on how these advancements are revolutionizing productivity and adherence to CGMP guidelines.

Yan Kugel⁠ is joined by Jakob Konradsen, the Co-Founder & Head of Quality at Eupry and here he discusses the importance of moving away from paper or PDF calibration certificates and manual work in the GXP industry. They explore the idea of using machine learning algorithms for auditing and the need for a business continuity plan for temperature control. The speaker emphasizes the value of being prepared for potential issues and encourages professionals to focus on improving emergency response plans. The episode ends with a recommendation to connect with the speaker on LinkedIn for further discussions on temperature control.

Yan Kugel⁠ is joined by Paul Sarrazin, an esteemed expert in good distribution practices (GDP) within the pharmaceutical sector. Here, he provides a glimpse into his journey from a permanent employee to a consultant specializing in GDP compliance. With a strong background in bioengineering and a rich portfolio of collaborations with industry giants like GSK, UCB, and Takeda, Paul's expertise in GDPs is rooted in his early consulting career and subsequent roles within pharmaceutical companies. Paul sheds light on the advantages of being a consultant in the pharmaceutical industry, emphasizing the autonomy and diversity of projects that come with the role.

In this episode, we welcome Jennifer Chang, a QA Intelligence Specialist at Blue Mountain. Yan Kugel and Jennifer discuss the impact of digital transformation on manufacturing processes, the challenges and benefits of compliance in the pharmaceutical industry, and companies' struggles in keeping up with regulators and taking a risk-based approach. They also explore why companies switch to digitized solutions and the importance of continuous learning in the pharmaceutical industry.

In this podcast episode, we had the pleasure of hosting Fabrizio Maniglio, an industry Business Development Director at Honeywell with a wealth of experience in Quality and Supply Chain Management within the life sciences sector. His insights into AI's transformative impact in the healthcare and pharmaceutical industries promise to make this conversation both enlightening and engaging. ------------------------------------------------------

The podcast is brought to you by ⁠Qualistery⁠, a leading provider of webinars, training, and consulting for the pharma industry.

For business inquiries, get in touch at info@qualistery.com.

------------------------------------------------------ Podcast Overview:

• The podcast episode features Fabrizio Maniglio, an experienced QA leader in the life sciences sector
• He discusses the future of AI in pharmaceuticals and the importance of digitalization and connected data
• The potential applications of AI in risk management and decision-making in the industry are highlighted
• The FDA is moving towards a risk management validation approach for AI in regulated spaces
• The discussion emphasizes the need for the pharma industry to drive change and not rely solely on regulators
• Companies are encouraged to experiment with AI technologies in low-stakes scenarios and use AI as a tool to solve specific problems
• The importance of staying current with AI trends and technology is emphasized, with recommendations for following the speaker on social media for more information on AI and potential future webinars.

In today's episode, we have a special guest, Harsh Thakkar, who has made a successful journey into consulting within the pharmaceutical industry. Harsh is a seasoned professional with extensive experience in advising on GXP practices and regulatory compliance. His career in consulting in the life science field is filled with insights, challenges, and triumphs that have shaped his career and made him a respected figure in the industry.

The podcast is brought to you by ⁠Qualistery⁠, a leading provider of webinars, training, and consulting for the pharma industry.

For business inquiries, get in touch at info@qualistery.com.

Yan Kugel is joined by Amar Badwy, the CEO at Pharmaoffer, to discuss digitalization in the pharma industry and the trends in the API market. They talk about the changes and challenges in the industry, the importance of personal relationships in business, and the need for a more approachable and visible online presence for API manufacturers. They also discuss the impact of the pandemic on digitization and the evolution of Pharmaoffer as a marketplace for APIs and service providers in the pharmaceutical industry. The conversation provides valuable insights for API manufacturers and pharma companies looking to connect and do business.

Episode Chapters:

1. Introduction and background (0:00 - 2:45)
2. Changes and trends in the API market (2:46 - 8:30)
3. Insights from analytics and understanding market needs (8:31 - 15:22)
4. Focus on the contract services market (15:23 - 19:40)
5. Acceptance of data sharing and challenges (19:41 - 25:10)
6. Connecting service providers in the pharma industry (25:11 - 30:45)
7. Conclusion and future plans (30:46 - 34:20)

The podcast is brought to you by Qualistery, a leading provider of webinars, training, and consulting for the pharma industry.

For business inquiries, get in touch at info@qualistery.com.

In this episode of the Qualitalks Podcast, we are honoured to have Toon Lambrechts as our guest. Toon is a self-proclaimed biotech nerd with an impressive background in the field of advanced cell and gene therapies. In this episode, we’ll dive into Toon’s passion for democratizing access to these life-changing therapies and explore his work as a co-founder of MyCellHub, a SaaS solution for biomanufacturing. We’ll also discuss the current state of data management and documentation practices in GMP environments and the challenges they pose for the industry. Plus, we will explore how MyCellHub’s toolkit is revolutionizing the biomanufacturing process by improving quality compliance and production times. Finally, we’ll shift gears towards Toon’s thoughts on the ever-evolving pharma industry amidst global events such as COVID-19. How will digitalization and data integration play a role in shaping the future of pharmaceuticals?

---------------------------------------

You can watch the video episode here. Learn more about GMP by joining our free educational webinars at www.qualistery.com.

In this podcast episode, Nathan Roman joins us to discuss the importance of temperature-controlled transport and the two types of storage solutions: active and passive.

He explains that the cold chain includes all food, medicine, drug products, and vaccine-related equipment and procedures. Nathan mentions that understanding temperature-controlled options is essential to ensure the best-controlled system is chosen to protect temperature-sensitive pharmaceutical products. He also discusses the pros and cons of these cooling solutions and suggests that the decision on which solution is best for your purpose should be based on your criteria, such as cost, electricity, and safety.

The conversation also covers the need to ensure that products arrive safely in the first mile of the supply chain and how to ensure that temperature-sensitive goods are transported, handled, and stored properly.

Tune in now to better understand cold chain solutions, how to monitor them, and how they can help you in your industry.

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at: https://podcast.qualistery.com/what-cold-chain-solutions-are-there-and-how-to-monitor-them-nathan-roman

------------------------------------------------------------------------------------------------------

This episode is sponsored by Eupry, a provider of state-of-the-art environmental monitoring systems.

Eupry supports the further development of a host of industries, including Laboratory, Pharmacy, Healthcare, Pharma, Food, and more, by providing efficient solutions to monitor temperature-sensitive assets.

Join us on our webinars and visit our website for more GMP insights, tips, and resources.

Don't miss out - follow Qualistery today!

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In the latest episode of Qualitalks, Yan Kugel and Nathan Roman dive deep into the world of qualification protocols and share their insights on writing effective ones.

Nathan explains that a qualification protocol is a written plan describing the qualification process and how the qualification will be conducted. He emphasizes the importance of understanding the project and its requirements and suggests using templates or a basic protocol format to ensure consistency in documentation preparation.

In addition, Nathan discusses the evolution of qualification protocols, including the incorporation of paperless validation and the need to stay up-to-date with new technologies.

Listening to the podcast, or watching the video, among others, you will learn about:

-What is a qualification protocol? 

-When should you have it ready? 

-What are the prerequisites? 

-What should it include? 

-And what are some common problems? 

Make sure you don't skip this enlightening and captivating dialogue. Listen in immediately!

 ----------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at: https://podcast.qualistery.com/temperature-mapping-all-you-need-to-know-about-good-qualification-protocol-nathan-roman/

------------------------------------------------------------------------------------------

This episode is Sponsored by Eupry, a provider of state-of-the-art environmental monitoring systems. Eupry supports the further development of a host of industries, including Laboratory, Pharmacy, Healthcare, Pharma, Food, and more, by providing efficient solutions to monitor temperature-sensitive assets.

Join us on our webinars and visit our website for more GMP insights, tips, and resources. Don't miss out - follow Qualistery today!

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

Are you looking to learn more about how to validate a temperature-controlled chamber? 

Look no further! In this episode, we have Nathan Roman, one of the top experts in Temperature control mapping, to help us understand the different steps and regulations when validating a temperature-controlled chamber in the Health & Life Science industries.

Nathan will share his knowledge on the need for temperature-controlled chambers, the various types of chambers, regulations, common mistakes to be avoided, and resources for keeping up with best practices

Topics range from:

• What a temperature-controlled Chamber is, and why are those needed?
• What types of temperature-controlled chambers are available,
• Which regulations exist, which steps of the validation process are most challenging,
• What common mistakes during the validation to avoid?
• Plus, get recommendations for resources to stay current with regulations and best practices.

-----------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at: https://podcast.qualistery.com/steps-to-validating-a-temperature-controlled-chamber-nathan-roman

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Eupry, a provider of state-of-the-art environmental monitoring systems. Eupry supports the further development of a host of industries, including Laboratory, Pharmacy, Healthcare, Pharma, Food, and more, by providing efficient solutions to monitor temperature-sensitive assets.

Join us on our webinars and visit our website for more GMP insights, tips, and resources.

Don't miss out - follow Qualistery today!

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

One of the most common concerns in GxP quality is maintaining the temperature of laboratory and manufacturing storage environments. Temperature Mapping, also known as thermal mapping, is an activity performed on temperature-controlled chambers often used to track temperature changes within the storage space over a long period.

This podcast episode focuses on the importance of temperature mapping studies and why they are so critical for pharmaceutical compliance. Our guest speaker is Nathan Roman, one of the top experts in Temperature control mapping who help people in the Health & Life Science industry learn how to implement and carry out temperature mapping studies and equipment qualifications (IQ, OQ, PQ).

Listing to the podcast, or watching the video, among others, you will learn about:

• What are temperature mapping studies, and why are they so critical for pharmaceutical compliance?
• Where is thermal mapping required, and why?
• What is the process for a temperature mapping study?
• What is the most challenging part of your job?
• What do most people do wrong with thermal mapping, and what would be your suggestion to improve?
• What resources can help pharma professionals stay updated with the latest regulations and trends?

So tune in to learn all there is to know about thermal mapping and its impact on pharmaceutical compliance!

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at: https://podcast.qualistery.com/what-is-thermal-mapping-and-why-its-so-important-nathan-roman/

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Eupry, a provider of state-of-the-art environmental monitoring systems. Eupry supports the further development of a host of industries, including Laboratory, Pharmacy, Healthcare, Pharma, Food, and more, by providing efficient solutions to monitor temperature-sensitive assets.

Join us on our webinars and visit our website for more GMP insights, tips, and resources. Don't miss out - follow Qualistery today!

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

Steve Galen has been involved in clinical trials for more than 27 years now, in various high-level positions. In this podcast episode, he will explain the different stages of the clinical trials and point out the most severe deficiencies in the industry and how to overcome there.

By listening to this episode of watching it, you will learn about:

• What is a clinical trial, and what's the main goal?
• What are the questions asked in clinical trials protocols?
• What are the parts of a clinical trial?
• How are those parts connected to the primary goal?
• What are the most common challenges with clinical trials nowadays?
• How can we make clinical trials more transparent and predictable?
• What are the goals of VC-funded biotech in early-stage clinical development versus pharma in later-stage clinical development, and how are these goals related to the primary purpose of a clinical trial?

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at https://podcast.qualistery.com/what-are-clinical-trials-and-and-how-to-solve-its-biggest-challenges

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast episode, our guest is Chris Maughan, a Sterilisation and Validation Consultant. 

Chris has spanned over 16 years with areas of expertise including validation compliance and consultancy support and training across Europe, the Middle East, Asia and the USA.

In this episode, you will learn about:

• What is the role of autoclave sterilization in the pharmaceutical industry?
  • What are some of the significant types of autoclaves in the market?
  • How to choose an autoclave for your needs?
  • How would you go about choosing a good vendor for autoclaves?
  • What should go in the URA for autoclaves?
  • What to check through all the qualification steps?
  • What routine tests should you run on autoclaves daily?

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-to-choose-and-qualify-autoclaves-and-what-pitfalls-to-avoid

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

Excipients are an integral part of any pill, and they are becoming more complex with time. The complexity plays a significant role from the regulatory aspect and their role in the drug's function.

In this podcast episode, our guest is Philippe Tschopp. Philippe is a Business Developer at Glatt Pharma and an enormous Excipient enthusiast.

Because of his passion, he found the website www.pharmaexcipients.com, where they post scientific insights about developments in the excipient world.

In this episode, Yan Kugel interviewed Philippe about the ever-changing excipient landscape and its role in drug manufacturing.

Listing to the podcast, or watching the video, among others, you will learn about:

• What makes excipients such an exciting field
• How pharmaexcipients.com was born, and what is its purpose?
• Where is the excipient market heading?
• What should change in the excipient world?
• What can be achieved by choosing the most optimal excipient for the novel drug?

------------------------------------------------------------------------------------------------------

Watch or Listen to the full podcast and read the article at https://podcast.qualistery.com/how-is-the-excipient-world-evolving

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast episode, our guest is Troy Fugate, a pharma industry and GMP veteran with 30+ years of experience in the field. Now, he is the Vice President at Compliance Insight, Inc. They help businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for manufacturing innovative drugs, medical devices, and biologics.

Troy believes that the single most challenging issue leaders face is incorporating GMPs into their company culture. The leaders don't know how to blend GMPs into their mission and vision with the right passion. Only then can employees see the whole vision and understand the "Why". Not just to do things because "it's required by the GMPs" but to see the value in those actions.

Listening to the podcast or watching the clip, you will learn:

• How to establish a unified quality mission across a pharma organization
• Why some people see GxP as a hurdle, and how to change that
• Why using KPIs wrong can cost you your best employees
• How to Deliver Effective and Measurable GMP training

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at https://podcast.qualistery.com/infusing-gxps-into-your-organizations-dna

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast episode, our guest is Marc García Gómez, a pharmaceutical contamination control strategy consultant. He is also the author of various articles in Spanish pharmaceutical magazines about cleaning and disinfection. During their talk, Marc discussed with Yan Kugel about the EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products draft and how it would affect pharma companies and their current contamination strategies.

Here are some of the things you'll learn about listening to or watching the podcast:

· A new dawn for microbiologists in the pharmaceutical industry

· What critical ideas Annex one introduces

· What new roles will the Maintenance department, upper management, and operators will have

· The importance of validating aseptic agents

· How to start preparing for the Annex 1 launch

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-will-the-revised-annex-1-impact-your-contamination-control-strategy

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Yan Kugel and our guest Jerry Chapman talk about how the landscape has changed over the years in the Pharma industry and what things have remained the same. In this episode, they discuss technological advancement in the pharmaceutical industry, what holds us back, and where we are headed.

Who is Jerry Chapman?

Currently working as Senior GMP Quality Expert at Redica Systems, Jerry has invaluable experience in the quality domain and implementation of international GMP regulations in quality policies. With experience spanning 40 years, he is helping to develop coursework on manufacturing deviation investigations and teaching the course to enable the personnel to conduct and properly document investigations.

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at https://podcast.qualistery.com/why-we-need-new-technology-in-gmp-and-what-stops-us

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, our guest is Jerry Chapman, a GMP expert with more than 40 years in the industry. Jerry and Yan talk about what has changed in pharma over the years and what has remained the same. He discusses the development of new courses as well as the importance of leadership training in the companies.

Who is Jerry Chapman?

Jerry Chapman is Senior GMP Quality Expert at Redica Systems. He brings over 40 years of experience in the pharma industry, including 31 years at Eli Lilly, where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality. At Redica Systems, Jerry works with the machine learning and data science teams. They build computer models that examine enforcement actions and produce analyses the way an expert would in the past using hard copy documents and a highlighter. He is also an author of many articles detailing and analyzing current hot topics among the pharma industry, and international regulators appear on the Redica Systems Conference Spotlight page.

Listening to the podcast, you will learn about:

● The Evolution of Pharma Industry

● FDA Training Requirements

● Required Skills in Quality Domain

● Why Generalists are a Bad Thing

● Better Methods for Training Experts and Leaders

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at www.podcast.qualistery.com/things-that-have-to-change-in-gmp-to-drive-success
------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Yan Kugel and our guest Megann Löffler talk about the new trends in the pharmaceutical industry, what you need to know about the market and what the companies are looking for. Her experience in the recruitment field enables her to give valuable insights that will potentially help you to build a successful career in the future.

Who Is Megan Löffler?

With an educational background in engineering coupled with an HR degree, Megann is currently working as a Talent Acquisition Manager at Headcount AG. It is a Zürich based consultancy serving clients in the pharmaceutical and biotechnology market segments. Megan has been working as a recruiter for six years, specializing in Pharma since the very start of her career. She is now building up her team within headcount and embracing management responsibilities and technical operations positions.

Listening to the Podcast, You Will Learn About:

● Innovations in the Pharmaceutical Industry

● Effect of New Developments on Recruiting Process

● Challenges for the New People in the Industry

● What Are Pharmaceutical Companies Looking for?

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at www.podcast.qualistery.com/how-to-build-a-successful-career-in-the-pharma-of-tomorrow

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Luis Charles Chavarría shares his invaluable insights from his 30-year career in the FDA. He explains how the FDA really operates, their main purpose during an audit, and sheds light on details you have probably never known about the FDA. 

Who Is Luis Charles Chavarría?

Luis has served in FDA for about three decades in several capacities that have earned him an unprecedented understanding of FDA affairs. He is currently working as President/Lead Consultant at Supaso International. He has also worked with the US Department of Justice and contributed to policymaking at the national as well as on the international level.

Reading the Article and Listening to the Podcast, You Will Learn About:

● What Does an FDA Agent Do?

● Difference Between an FDA Investigator and a Regular Quality Auditor

● Evidence Development by an FDA Investigator

● Procedures for Foreign-Based Manufacturing Units

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at www.podcast.qualistery.com/guide-to-preparing-yourself-for-an-fda-audit/

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, we have with us Yan Leyfman, MD. We will discuss and ask Dr. Leyfman about his views regarding how medicine and medical research will look in the future and the role of Artificial Intelligence and Personalized Medicine in disease treatment and the future of medicine. We will also ask Dr. Leyfman about some of his extraordinary career and life experiences.

Who Is Yan Leyfman?

Yan Leyfman, MD, is a medical doctor and a passionate researcher. His areas of command and interest are immunology, and oncology, i.e., the study of cancer. He is a survivor of the Chernobyl Nuclear Disaster in the USSR, and this incident deeply connects with his career and life ambitions.

Listening to the podcast, you will learn about:

● Dr. Leyfman's Career Inspiration and His Services in COVID-19 Pandemic

● What Factors Hinder Progress in Medical Research?

● Role of Artificial Intelligence (AI) in the Future of Medicine

● What Does the Future of Personalized Medicine Look Like?

● What Could Be the Next Breakthrough in Medicine?

● COVID-19 Pandemic for the Future of Medicine

------------------------------------------------------------------------------------------------------

Learn More About GMP at www.qualistery.com.

Watch or read the full podcast and read the article at www.podcast.qualistery.com/how-does-the-future-of-medicine-look-like/

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, we talk about CMOs and CDMOs, i.e., Contract Manufacturing Organizations.

What they are, how they work, their past and expected future, and everything you need to know about them as a startup, a company, or just as an individual. 

Our highly experienced and knowledgeable guest for this session is Kurt in Albon.

Kurt is Global Head of Information Quality at Lonza, one of the biggest CMOs in the world. He has been in the pharmaceutical industry for more than 25 years and holds leading-edge expertise in data integrity, pharmaceutical validation, international team management, and computer science.

For this special episode, co-hosting alongside Yan Kugel is Ammar Badwy. Ammar is CEO and co-founder at Pharmaoffer, an online business-to-business platform for pharmaceutical ingredients.

In this podcast, you will learn:

● What are CMOs or CDMOs and what do they do?

● History of CMOs - How long have they been there?

● How to find the right CMO/CDMO?

● How does a contract manufacturing organization earn?

● What is the future of contract manufacturing?

● Some more interesting information about CMOs/CDMOs

------------------------------------------------------------------------------------------------------

Learn More About GMP at www.qualistery.com.

Watch or read the full podcast and read the article at podcast.qualistery.com.

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready to use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Yan Kugel and our guest Rizgar Saltik talk about networking, branding, and marketing using LinkedIn, arguably the best online platform for professionals and business interactions. They also discuss using LinkedIn marketing to grow a robust business network as a pharma company, business, or independent entity.

Who Is Rizgar Saltik?

Currently working as a partner and consultant at Sciential, Rizgar is life sciences and health entrepreneur specializing in Digital Marketing and Consultancy. He has an educational background in Neurobiology and Business Management. Rizgar has been behind the success of more than 25 medical technology and biotechnology-related product launches and their commercialization.

In This Blog Post, You Will Learn:

● Why Are More People Using LinkedIn Now?

● How to Use LinkedIn for Networking?

● How to Use LinkedIn for Personal Branding?

● How to Use LinkedIn Marketing for Growing Your Business?

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-to-use-linkedin-marketing-to-grow-a-powerful-business-network/

Ask questions and learn about GMP here: www.qualistery.com.

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier. Learn more about them here: https://is.gd/l8BTWt

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast with Kurt In Albon, we will look at the concept of true leadership and its importance in the pharmaceutical industry. Kurt will tell us what essential qualities are required to be a successful leader, what pharma companies should look for when hiring talent, and some valuable tips for people who aspire leadership.

Kurt is Global Head of Information Quality at Lonza, one of the biggest CMOs in the world. He has been in the pharmaceutical industry for over 25 years and holds leading-edge expertise in data integrity, pharmaceutical validation, international team management, and computer science.

● What Is Leadership and Why Is It Important in the Pharma Industry?

● How Is a Leader Different From a Manager?

● What Should Companies Look For in Employees When Hiring?

● Situational Leadership in Pharmaceutical Industry: Does That Work?

● How Can You Become a Good Leader in the Pharmaceutical Industry?

------------------------------------------------------------------------------------------------------

Watch or read the full podcast and read the article at podcast.qualistery.com.

Ask questions and learn about GMP here: www.qualistery.com.

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, we have Philippe Tschopp from Glatt Pharmaceutical Services, a specialized CDMO. We will discuss with Philippe about CDMOs, what they are, how they work, and what a customer should look for in them. We’ll also ask him about Glatt Group as an example of how CMDOs work.

Who is Philippe Tschopp?

Philippe is the head of business development at Glatt Pharmaceutical Services. He has solid experience of well over a decade in business, sales and B2B digital marketing. He is also hugely enthusiastic about excipients and solid dosage forms.

Introducing our Co-Host:

Co-hosting this session alongside Yan Kugel is Ammar Badwy. Ammar is CEO and co-founder at Pharmaoffer, an online business-to-business platform for pharmaceutical ingredients.

In this blog post, you will learn:

● What is a CDMO and what it does?

● Glatt Group as a CDMO

● How to choose the right CDMO

● How Glatt Group deals with a project as a CDMO

● The trend of CDMOs in the near future

------------------------------------------------------------------------------------------------------

Learn More About GMP at www.qualistery.com.

Watch or read the full podcast and read the article at podcast.qualistery.com.

------------------------------------------------------------------------------------------------------

This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Yan Kugel and our guest, Àngels Llarch, talk about how pharma companies should host external audits. Àngels shares some really insightful tips regarding hosting an audit, coming right from her 20 years of vast experience in the pharmaceutical industry.

Currently working as API Compliance Head/Deputy RP at IMCD Switzerland AG, Àngels has more than two decades of solid experience, working in the Quality domain for several renowned pharmaceutical suppliers. She loves audits as they serve as a tool to discover new ways of implementing good manufacturing practices across the industry.

● What is an audit, and why is it performed?

● Do audits lead to the opening of pandora's boxes?

● How to prepare for an external audit

● Golden rules for hosting external audits by Àngels Llarch

● How to build trust with your auditor

Learn more about GMP on www.qualistery.com

Watch, listen or read the article on podcast.qualistery.com

Christy Mazzarisi is the Global Lead of Quality at CGI, supporting clients with automation quality systems.

In this episode, Christy talks to Yan Kugel and sheds light on the complex world of pharmaceutical automation and AI.

Listening to or watching this Qualitalks Podcast episode, you will learn about:

• What is the difference between intelligent automation (IA) and Artificial Intelligence (AI)?
• What is the value of AI and IA to pharmaceutical quality?
• How much money, time, and resources can AI and IA systems save for an organization?
• How to build and implement proper AI and AI networks?
• What are the challenges and the solution for AI and AI implementation?

Watch the full video episode on podcast.qualistery.com 

Learn more about GMP on www.qualistery.com

Find GxP consultancy work on www.paragonspoint.com

Yuval Shapiro is the founder of Quality with Value Ltd. A company that provides QA/RA for Medical Devices Services.

Yuval is a Quality Assurance & Regulatory Affairs Expert and consultant for products and companies primarily related to medical devices and telecom sectors. Additionally, he is a black belt Six Sigma certified from Johnson & Johnson. 

In this podcast episode, he discusses with Yan Kugel the history and evolution of Quality and why we are witnessing the death of Quality in his opinion. Then, he explains how to save it!

Watch the full video episodes on podcast.qualistery.com

Learn about quality and GMP for the top experts in the industry at www.qualistery.com

Suzzane Studinger has been a GMP consultant for over 9 years now. In this podcast episode, she explains why she decided to leave her steady job by Roche to become an independent consultant. She also reveals what the REAL job of the consultant is, what the challenges are behind it, and gives advice for employers for making the best of their consultants.

Watch the full video episode here.

James Ainsworth is a software developer who started supporting businesses with ERP deployment and CSV about ten years ago. Besides the pharmaceutical and biotech sectors, James has experience consulting companies in other highly regulated industries such as Automotive and Fintech.

In this podcast episode, James spoke to Yan Kugel about CSV and its essential parts, about which you don't learn in training.

Here are some of the topics you will hear about:

• The most challenging parts of CSV are not what you think they are.
• The real objectives of CSV.
• What's more critical in CSV than CSV?
• What is the role of the QA in CSV?
• What are the functions of the CSV lead?
• How to manage sake holders?
• The reasons why companies should hire external CSV leads.

Watch the full video episode on podcast.qualistery.com.

Master GMP on www.qualistery.com.