The Qualitalks Podcast
Activity Overview
Episode publication activity over the past year
Episodes
Agility in Pharma: Transforming Challenges into Opportunities [Elizabeth Hickman]
26 Nov 2024
Contributed by Lukas
Yan Kugel is joined by Elizabeth Hickman, the Chief Business Officer at AustinPx. With over a decade of experience in the biotech and pharmaceutical ...
Risks and Rewards in GMP Process Automation [Will Moss] #77
03 Sep 2024
Contributed by Lukas
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 e...
Navigating Workplace Dynamics as a Woman in Leadership- Christy Mazzarisi #76
27 Aug 2024
Contributed by Lukas
In this episode, Yan Kugel is joined by Christy Mazzarisi, a distinguished leader in the pharmaceutical industry with extensive experience in quality...
Pharma Trends: The Return of the FDA Warning Letters - Simone Ammons - #75
21 Aug 2024
Contributed by Lukas
In this episode, Yan Kugel is joined by Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse indus...
The Impact of AI on Patent Research and Analysis in the Pharma [Ben Coverdale] #74
13 Aug 2024
Contributed by Lukas
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 science...
Navigating Complexity: Challenges and Solutions in Pharma 4.0 [Pavan Pasupulati] #73
06 Aug 2024
Contributed by Lukas
Yan Kugel is joined by Pavan Pasupulati, the Vice President of Manufacturing Excellence at Caliber Technologies. Here, he shares valuable insights in...
Navigating FDA Inspections: Things You Should Never Say! [Vincent F. Cafiso] #72
31 Jul 2024
Contributed by Lukas
Yan Kugel is joined by Vincent F. Cafiso, the Director of Quality and Regulatory Services at CREO Consultancy and a former FDA investigator. Vincen...
The Strategic Journey of Pharmaceutical Commercialization [Mohamed Amer] - #71
23 Jul 2024
Contributed by Lukas
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...
Improving Processes: Insights and Transitions [Kelly Stanton]#70
16 Jul 2024
Contributed by Lukas
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 ...
Revolutionizing Validation and Automation in Biotech [Nagesh Nama] - #69
09 Jul 2024
Contributed by Lukas
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...
Navigating Communication Challenges in Quality-Driven Environments [Lesley Worthington] #68
02 Jul 2024
Contributed by Lukas
Yan Kugel is joined by Lesley Worthington, a communication and leadership coach for quality professionals. Together, they discussed the significan...
Experimenting with AI in Pharma: A Question of Time [Vasyl Chumachenko]
25 Jun 2024
Contributed by Lukas
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 Va...
Enhancing Compliance and Efficiency in Pharma Manufacturing with AI [Vivek Gera]
18 Jun 2024
Contributed by Lukas
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 cutt...
Revolutionizing Temperature Control in Pharma [Jakob Konradsen]
11 Jun 2024
Contributed by Lukas
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 pap...
How to Navigate GDP Compliance in Pharma [Paul Sarrazin]
04 Jun 2024
Contributed by Lukas
Yan Kugel is joined by Paul Sarrazin, an esteemed expert in good distribution practices (GDP) within the pharmaceutical sector. Here, he provides ...
Navigating the World of Asset Management and Quality Assurance [Jennifer Chang]
29 May 2024
Contributed by Lukas
In this episode, we welcome Jennifer Chang, a QA Intelligence Specialist at Blue Mountain. Yan Kugel and Jennifer discuss the impact of digital transf...
Unleashing the Power of AI in Pharma [Fabrizio Maniglio]
22 May 2024
Contributed by Lukas
In this podcast episode, we had the pleasure of hosting Fabrizio Maniglio, an industry Business Development Director at Honeywell with a wealth of exp...
Breaking Barriers: How to Build a Successful Career in GMP Consulting [Harsh Thakkar]
15 May 2024
Contributed by Lukas
In today's episode, we have a special guest, Harsh Thakkar, who has made a successful journey into consulting within the pharmaceutical industry. ...
Empowering Pharma Partnerships with Digitalization [Ammar Badwy]
08 May 2024
Contributed by Lukas
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 tal...
Improving Manufacturing Efficiency and Compliance with Toon Lambrechts
20 Jun 2023
Contributed by Lukas
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 impres...
What Cold Chain Solutions Are There and How to Monitor Them [Nathan Roman]
29 Mar 2023
Contributed by Lukas
In this podcast episode, Nathan Roman joins us to discuss the importance of temperature-controlled transport and the two types of storage solutions: a...
Temperature Mapping - All You need to Know About Good Qualification Protocols [Nathan Roman]
22 Mar 2023
Contributed by Lukas
In the latest episode of Qualitalks, Yan Kugel and Nathan Roman dive deep into the world of qualification protocols and share their insights on writin...
Steps to Validating a Temperature Controlled Chamber [Nathan Roman]
16 Mar 2023
Contributed by Lukas
Are you looking to learn more about how to validate a temperature-controlled chamber? Look no further! In this episode, we have Nathan Roman, on...
What Is Thermal Mapping and Why It’s So Important [Nathan Roman]
09 Mar 2023
Contributed by Lukas
One of the most common concerns in GxP quality is maintaining the temperature of laboratory and manufacturing storage environments. Temperature Mappin...
What Are Clinical Trials and and How to Solve Its Biggest Challenges [Steve Galen]
11 May 2022
Contributed by Lukas
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...
How to Choose and Qualify Autoclaves and What Pitfalls to Avoid [Chris Maughan]
13 Apr 2022
Contributed by Lukas
In this podcast episode, our guest is Chris Maughan, a Sterilisation and Validation Consultant. Chris has spanned over 16 years with areas of ex...
How Is the Excipient World Evolving [Philippe Tschopp]
02 Mar 2022
Contributed by Lukas
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...
Incorporating GxPs to Your Company's DNA [Troy Fugate]
05 Jan 2022
Contributed by Lukas
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 Pr...
How Will the Revised Annex 1 Impact Your Contamination Control Strategy
15 Dec 2021
Contributed by Lukas
In this podcast episode, our guest is Marc García Gómez, a pharmaceutical contamination control strategy consultant. He is also the author of variou...
Why We Need New Technology in GMP and What Stops Us
11 Dec 2021
Contributed by Lukas
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 ...
Things That Have to Change in GMP to Drive Success [Jerry Chapman]
20 Oct 2021
Contributed by Lukas
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...
How to Build a Successful Career in the Pharma of Tomorrow [Megann Löffler]
06 Oct 2021
Contributed by Lukas
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 mar...
FDA Insider Secrets - All You Need To Know To Avoid A Warning Letter [Luis Charles Chavarría]
22 Sep 2021
Contributed by Lukas
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, t...
How Does the Future of Medicine Look Like?
08 Sep 2021
Contributed by Lukas
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...
What are CMOs and what are they good for (Part 1) [Kurt In Albon from Lonza]
25 Aug 2021
Contributed by Lukas
In this podcast, we talk about CMOs and CDMOs, i.e., Contract Manufacturing Organizations. What they are, how they work, their past and expected futur...
How To Use LinkedIn To Grow a Powerful Business Network
25 Aug 2021
Contributed by Lukas
In this podcast, Yan Kugel and our guest Rizgar Saltik talk about networking, branding, and marketing using LinkedIn, arguably the best online platfor...
Leadership Lessons From the Head of Global Information Quality at Lonza
18 Aug 2021
Contributed by Lukas
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 u...
What Are CMOS and What Are They Good For? (Part 2) [Phillipe Tschopp from Glatt]
11 Aug 2021
Contributed by Lukas
In this podcast, we have Philippe Tschopp from Glatt Pharmaceutical Services, a specialized CDMO. We will discuss with Philippe about CDMOs, what they...
The Golden Rules of Hosting an Audit [Àngels Llarch]
14 Jul 2021
Contributed by Lukas
In this podcast, Yan Kugel and our guest, Àngels Llarch, talk about how pharma companies should host external audits. Àngels shares some really insi...
How Artificial and Automated Intelligence Change the Pharmaceutical Landscape [Christy Mazzarisi]
16 May 2021
Contributed by Lukas
Christy Mazzarisi is the Global Lead of Quality at CGI, supporting clients with automation quality systems. In this episode, Christy talks to Yan Kuge...
The Death of Quality [Yuval Shapiro]
02 May 2021
Contributed by Lukas
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 &...
The Challenges of a GMP Consultant [Suzanne Studinger]
11 Apr 2021
Contributed by Lukas
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 Roc...
What They Don't Teach You in CSV Training [James Ainsworth]
06 Mar 2021
Contributed by Lukas
James Ainsworth is a software developer who started supporting businesses with ERP deployment and CSV about ten years ago. Besides the pharmaceutical ...
Unconventional Approach to Pharmaceutical QA and GMP [Yaron Ziv]
31 Jan 2021
Contributed by Lukas
"QA is a service provider and not a slave of the regulations." -Yaron Ziv Yaron is a pharmacist and the Head...
Data Integrity - Connecting the Dots [Galit Lisaey]
17 Jan 2021
Contributed by Lukas
In this podcast episode, Yan Kugel talked to Galit Lisaey about connecting the dots in data integrity. Galit Lisaey is a Data Integrity consultant and...
GMP Training The Right Way [Dominic Parry]
03 Jan 2021
Contributed by Lukas
GMP training is mandatory, but nobody explains how to conduct it correctly, effectively, or measure results. Dominic Parry is the Director of Inspired...
Digital Solutions and Commercial Success in Pharma [Davidek Herron]
20 Dec 2020
Contributed by Lukas
Davidek Herron is the Head of Global Digital Platforms & Operations at Teva Pharmaceuticals. His mission in Teva is to leverage digital technologi...
How To Qualify Your Equipment 101 [Vlatko Kantardjioski]
06 Dec 2020
Contributed by Lukas
In this podcast episode, Vlatko Kantardjioski gives an amazing overview of equipment qualification in the pharmaceutical industry. Vlatko is a Quality...
What Are Cloud Services and How to Validate Them [Borislav Milev]
22 Nov 2020
Contributed by Lukas
Do you know what cloud computing is and how to validate it for pharma use? You will know by the end of this episode. More and more software become clo...
How to Deal With Risk in Pharma [Alex Hall]
08 Nov 2020
Contributed by Lukas
Risk management is a crucial part of the pharmaceutical quality management system. Unfortunately, many companies don't get it right and don't understa...
How To Validate Your Computerized Systems [Daniel Milek]
25 Oct 2020
Contributed by Lukas
Computer system validation (CSV) is more crucial now than ever. The reason for that is the digital transformation that pharma companies undergo in rec...
How to Successfully Deal With Deviations [Paul Palmer]
11 Oct 2020
Contributed by Lukas
GMP Professionals have to deal with deviations daily, and one must admit that it is not the best part of the day. However, deviations are a crucial pa...
What Is the Role of the Pharma Consultant and How to Become One [Thomas McMann]
04 Oct 2020
Contributed by Lukas
In this episode of The Qualitalks Podcast, Yan Kugel interviewed Thomas McMann about the role of Contractors & Consultants in the pharmaceutical i...
This Is How AI Will Help You Conduct an Audit [CALIDAD AI]
27 Sep 2020
Contributed by Lukas
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 f...
How to Prepare Well for Regulatory Audits [Paul Palmer]
20 Sep 2020
Contributed by Lukas
Quality indeed means doing it right when no one is looking. However, preparing well for a regulatory audit is a vital task. A good preparation may tur...
Who Are Qualifyze and What Is Their Mission?
13 Sep 2020
Contributed by Lukas
At Qualistery, we love talking to innovators within the pharmaceutical world. In this episode, Yan Kugel interviewed Florian Hildebrand and Carl...
Why Data Integrity Is More Important Than Ever [Daniel Milek]
06 Sep 2020
Contributed by Lukas
Data integrity is a big deal nowadays, and many companies get warning letters due to non-conformities in this area. In this podcast, Daniel Milek, a D...
How to Combat the Two Major Deficiencies in Pharma [Yogesh Krishan Davé]
30 Aug 2020
Contributed by Lukas
Yogesh Krishan Davé has been working in the pharmaceutical industry for more than 40 years now. He is an EU Qualified Person and a consultant. During...
Finding New Qualified Suppliers Doesn't Have to Be Hard [Ammar Badwy]
23 Aug 2020
Contributed by Lukas
During his work in various pharmaceutical industry roles, Ammar Badwy has understood how difficult it is to find suppliers of raw materials that meet ...
When You Deal With Risk, Don't Be a Firefighter! [Alex Hall]
16 Aug 2020
Contributed by Lukas
In this episode of the Qualitalks Podcast, Alex Hall and Yan Kugel discussed Risk Management in the pharmaceutical industry. Risk Management is a crit...
How to Choose and Implement the Right eQMS for Your Company [Doron Sitbon]
09 Aug 2020
Contributed by Lukas
Digital transformation is the future of the pharmaceutical industry. Having an electronic quality management system (eQMS) in place means better effic...
How To Build a Successful Career in Pharma [Matthew Lancaster]
02 Aug 2020
Contributed by Lukas
The pharmaceutical industry is very lucrative and offers many employment possibilities. However, finding the right position for starting or advancing ...
How To Successfully Conduct and Document an Audit [Jennifer Kussauer]
26 Jul 2020
Contributed by Lukas
In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor. Jennifer talks and gives practical advi...
How to Prepare for an Audit as a GxP Inspector
19 Jul 2020
Contributed by Lukas
In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor. Here are some of the topic...
How To Design Aseptic Manufacturing For Best Compliance
05 Jul 2020
Contributed by Lukas
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 des...
How Good Headhunters Can Benefit Your Career (Part 1)
21 Jun 2020
Contributed by Lukas
Working in the pharmaceutical industry has its perk, as there are countless opportunities for career advancement. However, finding the right opportuni...
How to Build a Successful Career in Pharma With Any Education
07 Jun 2020
Contributed by Lukas
Building a successful career in pharma is complicated and requires specific tools, knowledge, and traits. But you can do it with any educational backg...
Why You Should Become a GMP Auditor and How to Do It
31 May 2020
Contributed by Lukas
Today, most experienced pharmaceutical professionals want to become quality auditors, but they are not guided well or not having that much information...
The Secrets to Success With Chinese Suppliers [Oliver Rhode]
25 May 2020
Contributed by Lukas
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...
Essential Time Management Tips for Pharma [Paul Palmer]
17 May 2020
Contributed by Lukas
Proper time management is essential for every worker in the pharmaceutical industry because many of the processes have strict deadlines. Not finishing...
Medicinal Combination Products - Dr. Michael Drues
10 May 2020
Contributed by Lukas
In this episode, Yan Kugel talked to Dr. Michael Drues about medicinal combination products. Michael is an internationally recognized expert and featu...
Covid-19: Critical Quality Measures for Pharmaceutical Production
03 May 2020
Contributed by Lukas
Due to the COVID-19 situation, governments across the world initiated lockdown and quarantines. The lockdowns have a severe impact on pharmaceutical m...
Validation - Pharma vs Medical Devices
26 Apr 2020
Contributed by Lukas
In this episode, Yan Kugel talks to José Sergio Ávila, a validation, and sterilization specialist, about validation activities in the pharmaceutical...
COVID-19 and the Drug Shortage From India
19 Apr 2020
Contributed by Lukas
Shoab Malek is a pharmaceutical consultant and a GMP auditor, located in India. He talked to Yan Kugel about the big challenges that India faces becau...
The Role of a Qualified Person (QP) in Europe
12 Apr 2020
Contributed by Lukas
In this episode of the Qualitalks Podcast, Alex Hall and I discuss the most crucial role of the Qualified Person in the pharmaceutical industry. Liste...
Quality Assurance Philosophy with Paul Palmer
05 Apr 2020
Contributed by Lukas
Paul Palmer and I talked about the quality assurance (QA) and Quality Control (QC) philosophy in organizations. Many companies don't get it right, and...
Welcome to the Qualitalks Podcast
15 Mar 2020
Contributed by Lukas
The pharmaceutical industry is a fascinating and complex field. Countless people work hard to release a quality product to the market. In the Qualital...