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Risks and Rewards in GMP Process Automation [Will Moss]
Yan Kugel is joined by Will Moss founder and CEO of Seal, to talk about the critical need for automation in GXP processes. Will shares his expertise on balancing automation […]
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Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons] Simone (George) Ammons
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Navigating Workplace Dynamics as a Woman in Leadership [Christy Mazzarisi]
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 […]
Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons]
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 QuneUp, a data-driven […]
The Impact of AI on Patent Research and Analysis in the Pharma [Ben Coverdale]
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 […]
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Navigating Complexity: Challenges and Solutions in Pharma 4.0 [Pavan Pasupulati]
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 […]
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Navigating FDA Inspections: Things You Should Never Say! [Vincent F. Cafiso]
Yan Kugel is joined by Vincent Cafiso, the Director of Quality and Regulatory Services at CREO Consultancy and a former FDA investigator. Vincent shares invaluable advice on things never to […]
The Strategic Journey of Pharmaceutical Commercialization [Mohamed Amer]
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 […]
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Improving Processes: Insights and Transitions [Kelly Stanton]
In this episode, Kelly discusses her experiences in the pharmaceutical industry and the challenges of implementing cloud-based software tools. She also shares insights on improving processes and the impact it […]
Revolutionizing Validation and Automation in Biotech [Nagesh Nama]
In this podcast episode, Nagesh Nama shares his expertise in incorporating AI into validated processes within the pharmaceutical industry. He discusses the benefits, challenges, and best practices of using AI […]
Navigating Communication Challenges in Quality-Driven Environments [Lesley Worthington]
Yan Kugel is joined by Lesley Worthington, a communication and leadership coach for quality professionals, to discuss the importance of interpersonal skills in quality assurance within the pharmaceutical industry. Lesley […]
Experimenting with AI in Pharma: A Question of Time [Vasyl Chumachenko]
Vasyl shares his expertise in integrating AI solutions into the pharmaceutical industry and the practical implications of driving innovation and growth. The conversation delves into the use of AI and […]
Enhancing Compliance and Efficiency in Pharma Manufacturing with AI [Vivek Gera]
Vivek shared his wealth of experience leveraging cutting-edge technologies to enhance compliance and operational efficiency within the pharmaceutical manufacturing industry. Throughout the episode, Vivek delved into the transformative impact of […]
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Revolutionizing Temperature Control in Pharma [Jakob Konradsen]
Jakob Konradsen, the co-founder and head of quality at Eupry emphasized the importance of data integrity and advanced statistical analysis in the pharmaceutical industry. He discussed the challenges related to […]
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How to Navigate GDP Compliance in Pharma [Paul Sarrazin]
Paul shares his wealth of experience and insights into innovative strategies and best practices for maintaining quality standards and regulatory compliance in the pharmaceutical supply chain. The discussion delves into […]
Navigating the World of Asset Management and Quality Assurance [Jennifer Chang]
Join us for an insightful conversation with Jennifer, a quality assurance expert in the life sciences industry. Learn about the challenges and best practices in regulatory compliance and how continuous […]
Unleashing the Power of AI in Pharma [Fabrizio Maniglio]
abrizio Manilio discusses the role of digitalization and AI in the life sciences industry. He shares insights into the future of technology, the importance of understanding capabilities, and the potential […]
Breaking Barriers: How to Build a Successful Career in GMP Consulting [Harsh Thakkar]
Our guest Harsh Thakkar shares valuable insights on building leverage, creating content, and the importance of online presence in the business world.
Empowering Pharma Partnerships with Digitalization [Ammar Badwy]
Explore digitalization in the pharma industry with Yan Kugel from Qualistery and Ammar Badwy from Pharmaoffer. Gain insights into trends in the API market, the impact of the pandemic, and […]
Improving Manufacturing Efficiency and Compliance with Toon Lambrechts
Join us as we dive into an insightful conversation with Toon Lambrechts, the Co-Founder of MyCellHub, in an exploration of advanced therapies and the democratization of access to life-changing treatments.
What Cold Chain Solutions Are There and How to Monitor Them [Nathan Roman]
In this podcast episode, Yan Kugel interviews Nathan Roman about the importance of temperature control in the supply chain industry, specifically in the cold chain.
Temperature Mapping – All You need to Know About Good Qualification Protocol [Nathan Roman]
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.
Steps to Validating a Temperature Controlled Chamber [Nathan Roman]
In this episode, Nathan Roman shares his knowledge of the different steps and regulations when validating a temperature-controlled chamber.
What Is Thermal Mapping and Why It’s So Important [Nathan Roman]
In this podcast episode, Nathan Roman, one of the top experts in Temperature control mapping, speaks about thermal mapping and its importance for pharmaceutical compliance.
What Are Clinical Trials and How to Solve Its Biggest Challenges
By listening to this episode of watching it, you will learn about: What Are Clinical Trials and How to Solve Its Biggest Challenges with Steve and Yan
How to Choose and Qualify Autoclaves and What Pitfalls to Avoid
In this podcast episode, our guest is Chris Maughan, a Sterilisation and Validation Consultant.
How Is the Excipient World Evolving
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 […]
Infusing GxPs Into Your Organization’s DNA
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 […]
How Will the Revised Annex 1 Impact Your Contamination Control Strategy
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 […]
Why We Need New Technology in GMP and What Stops Us
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 […]
Things That Have to Change in GMP to Drive Success
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 […]
How To Build A Successful Career In The Pharma Of Tomorrow
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 […]
What You Didn’t Know About FDA: Guide to Preparing Yourself for an FDA Audit
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, […]
How Does the Future of Medicine Look Like?
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 […]
How To Use LinkedIn Marketing To Grow a Powerful Business Network
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 […]
Leadership Lessons From the Head of Global Information Quality at Lonza
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 […]
What Are CMOS and What Are They Good For? (Part 2) [Phillipe Tschopp from Glatt]
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 […]
What are CMOs and what are they good for (Part 1 – Lonza) [Kurt In Albon]
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 […]
How Artificial and Automated Intelligence Change the Pharmaceutical Landscape
In this podcast episode, Christy Mazzarisi sheds light on artificial and automated intelligence in the Pharmaceutical GMP Industry.
The Death of Quality
Yuval Shapiro is a Quality expert and Six Sigma black belt. In this podcast episode he explains why quality is dying & how to save it.
The Challenges of a GMP Consultant
Why would you leave a steady job to become a GMP consultant? Suzzane Studinger gives the answers in this Qualitalks Podcast episode.
What they don’t teach you in CSV training
In this podcast episode you will learn about crucial parts of CSV that nobody teaches you during official training.
Data Integrity – Connecting the Dots
In this podcast episode, Yan Kugel talked to Galit Lisaey about connecting the dots in data integrity.
GMP Training The Right Way
Dominic Parry is the Director of Inspired Pharma and he explains how to perform effective GMP training and test effectiveness.
What Are Cloud Services and How to Validate Them
Borislav Milev is a CSV expert. In this podcast episode, he explains what cloud computing is and how to validate it in a GMP environment.
How to Deal With Risk in Pharma
Risk management is a crucial part of the pharmaceutical quality management system. Unfraternally, many companies don’t get it right and don’t understand how to use ICH Q9 correctly. In this […]
How To Validate Your Computerized Systems
In this podcast episode, Daniel Milek, a CSV expert from Data Integral Ltd, provides precious guidance on how you should go about your system validations.
How to Successfully Deal With Deviations
In this podcast episode, Paul Palmer explains what types of deviations are there and how to deal with them successfully.
What Is the Role of the Pharma Consultant and How to Become One
Working in a permanent job has its benefits, but also being an independent contractor or consultant. This work can be fantastic for many people who work in the pharmaceutical industry, […]
This Is How AI Will Help You Conduct an Audit
In this episode of The Qualitalks Podcast, Yan Kugel talked to Dr. Rhett Pascual, Ken Toley, and Dr. David Guy Brizan. They are the team responsible for CALIDAD.AI, a company […]
How to Prepare Well for Regulatory Audits
In this episode, Yan Kugel has interviewed Paul Palmer on how to prepare correctly for a regulatory GMP audit.
Finding New Qualified Suppliers Doesn’t Have to Be Hard
During his work in various pharmaceutical industry roles, Ammar Badwy has understood how difficult it is to find suppliers of raw materials that meet all the requirements. Therefore, Ammar has […]
When You Deal With Risk, Don’t Be a Firefighter!
Risk Management is a critical topic that is, unfortunately, misunderstood by many pharmaceutical companies. Many take the reactive approach instead of the proactive one, and that can cause them a […]
How to Choose and Implement the Right eQMS for Your Company
Digital transformation is the future of the pharmaceutical industry. Having an electronic quality management system (eQMS) in place means better efficiency, convenience, and compliance. However, the transformation is not a […]
How To Build a Successful Career in Pharma
The pharmaceutical industry is very lucrative and offers many employment possibilities. However, finding the right position for starting or advancing your career may present itself as challenging. To help you […]
How To Successfully Conduct and Document an Audit
Jennifer talks and gives practical advice on how to perform a successful supplier or internal audit from start to finish.
How to Prepare for an Audit as a GxP Inspector
In this episode of the Qualitalks Podcast, you will learn how to prepare for audits as a GMP and a GxP auditor.
How to Design Aseptic Manufacturing for Best Compliance
The manufacturing of sterile drugs is a critical and essential process. For the process to conform to the strict GMP requirement, it is crucial to design every aspect of the […]
How Good Headhunters Can Benefit Your Career in Pharma
Working in the pharmaceutical industry has its perk, as there are countless opportunities for career advancement. However, finding the right opportunities in the vast GMP world can be challenging. Therefore, […]
How To Build A Successful Career In Pharma With Any Education
Building a successful career in pharma is complicated and requires specific tools, knowledge, and traits. But you can do it with any educational background if you have a healthy hunger […]
Why You Should Become a GMP Auditor and How to Do It
Today, most experienced pharmaceutical professionals want to become quality auditors, but they are not guided well or not having that much information about how to do it. By listening to […]
The Secrets to Success With Chinese Suppliers
China is the most crucial supplier of chemicals to the pharmaceutical industry because it is not easy to find the alternatives that they have to offer. But there is a […]
Essential Time Management in Pharma
Proper time management is essential for every worker in the pharmaceutical industry because many of the processes have strict deadlines. Not finishing tasks on time may lead to non-compliance.
Medicinal Combination Products
In this episode, Yan Kugel talked to Dr. Michael Drues about medicinal combination products. Michael is an internationally recognized expert and featured keynote speaker on cutting edge medical technologies and […]
Covid-19: Critical Quality Measures for Pharmaceutical Production
Due to the COVID-19 situation, governments across the world initiated lockdown and quarantines. The lockdowns have a severe impact on pharmaceutical manufacturing across the globe.
Validation – Pharma vs Medical Devices
In this episode, Yan Kugel talked to José Sergio Ávila, a validation, and sterilization specialist, about validation activities in the pharmaceutical and medical devices industries.
Covid-19 – the Devastating Impact on the Indian Pharma Industry
Shoab Malek is a pharmaceutical consultant and a GMP auditor, located in India. Malek talked to Yan Kugel about the big challenges that India faces because of COVID-19. Being the […]
The Role of the Qualified Person (QP)
In this episode of the Qualitalks Podcast, Alex Hall and Yan Kugel discuss the crucial role of the Qualified Person in the pharmaceutical industry. Alex also provides great tips on […]
Quality Assurance Philosophy
Paul Palmer and Yan Kugel talked about the quality assurance (QA) and Quality Control (QC) philosophy in organizations. Many companies don’t get it right, and it costs them in compliance, […]