Shows
The Qualitalks PodcastAgility in Pharma: Transforming Challenges into Opportunities [Elizabeth Hickman]
Yan Kugel is joined by Elizabeth Hickman, the Chief Business Officer 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.
2024-11-2733 minThe Qualitalks PodcastRisks and Rewards in GMP Process Automation [Will Moss] #77
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.
2024-09-0443 minThe Qualitalks PodcastNavigating Workplace Dynamics as a Woman in Leadership- Christy Mazzarisi #76
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.
2024-08-2851 minThe Qualitalks PodcastPharma Trends: The Return of the FDA Warning Letters - Simone Ammons - #75
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.
2024-08-2146 minThe Qualitalks PodcastThe Impact of AI on Patent Research and Analysis in the Pharma [Ben Coverdale] #74In 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.
2024-08-1439 minThe Qualitalks PodcastNavigating Complexity: Challenges and Solutions in Pharma 4.0 [Pavan Pasupulati] #73Yan 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.
2024-08-0739 minThe Qualitalks PodcastNavigating FDA Inspections: Things You Should Never Say! [Vincent F. Cafiso] #72Yan 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.
2024-07-3157 minThe Qualitalks PodcastThe Strategic Journey of Pharmaceutical Commercialization [Mohamed Amer] - #71
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.
2024-07-2452 minThe Qualitalks PodcastImproving Processes: Insights and Transitions [Kelly Stanton]#70In 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...2024-07-1753 minThe Qualitalks PodcastRevolutionizing Validation and Automation in Biotech [Nagesh Nama] - #69
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.
2024-07-1037 minThe Qualitalks PodcastNavigating Communication Challenges in Quality-Driven Environments [Lesley Worthington] #68
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.
2024-07-0350 minThe Qualitalks PodcastExperimenting with AI in Pharma: A Question of Time [Vasyl Chumachenko]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.2024-06-2647 minThe Qualitalks PodcastEnhancing Compliance and Efficiency in Pharma Manufacturing with AI [Vivek Gera]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.
2024-06-1955 minThe Qualitalks PodcastRevolutionizing Temperature Control in Pharma [Jakob Konradsen]
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.
2024-06-1253 minThe Qualitalks PodcastHow to Navigate GDP Compliance in Pharma [Paul Sarrazin]
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 th...2024-06-0552 minThe Qualitalks PodcastNavigating the World of Asset Management and Quality Assurance [Jennifer Chang]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.
2024-05-2950 minThe Qualitalks PodcastUnleashing the Power of AI in Pharma [Fabrizio Maniglio]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 epis...2024-05-2248 minThe Qualitalks PodcastBreaking Barriers: How to Build a Successful Career in GMP Consulting [Harsh Thakkar]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 t...2024-05-1552 minThe Qualitalks PodcastEmpowering Pharma Partnerships with Digitalization [Ammar Badwy]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...2024-05-0855 minThe Qualitalks PodcastImproving Manufacturing Efficiency and Compliance with Toon LambrechtsIn 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 revol...2023-06-2038 min
The Qualitalks PodcastWhat Cold Chain Solutions Are There and How to Monitor Them [Nathan Roman]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...2023-03-3025 min
The Qualitalks PodcastTemperature Mapping - All You need to Know About Good Qualification Protocols [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.
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...2023-03-2221 min
The Qualitalks PodcastSteps to Validating a Temperature Controlled Chamber [Nathan Roman]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 a...2023-03-1617 min
The Qualitalks PodcastWhat Is Thermal Mapping and Why It’s So Important [Nathan Roman]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...2023-03-0916 min
Life Sciences 360🔥 Why GMP Training Is Boring & How to Fix It | QA Audits & Personal Branding Tips w/ Yan KugelIn this episode, Harsh Thakkar (@harshvthakkar) sits down with Yan Kugel (@yankugel), Managing Director at Qualistery and host of the QualiTalks podcast.Yan reveals how he’s making GMP learning more engaging, his insights on QA audits, and expert tips for life science professionals to build a strong personal brand on LinkedIn. If you're in quality assurance, GMP training, or life sciences, this is a must-watch!Topics Covered:📌 (1:48) - Mastering Quality Assurance📌 (6:25) - Why GMP Training Is Boring (And How to Fix It)📌 (14:23) - Lessons from QA Audits📌 (20:14) - Personal Branding for Life Scien...2023-02-2340 min
The Qualitalks PodcastWhat Are Clinical Trials and and How to Solve Its Biggest Challenges [Steve Galen]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...2022-05-1148 min
The Qualitalks PodcastHow to Choose and Qualify Autoclaves and What Pitfalls to Avoid [Chris Maughan]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 U...2022-04-1332 min
The Qualitalks PodcastHow Is the Excipient World Evolving [Philippe Tschopp]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...2022-03-0228 min
The Qualitalks PodcastIncorporating GxPs to Your Company's DNA [Troy Fugate]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...2022-01-0534 min
The Qualitalks PodcastHow Will the Revised Annex 1 Impact Your Contamination Control StrategyIn 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 Anne...2021-12-1521 min
The Qualitalks PodcastWhy We Need New Technology in GMP and What Stops UsIn 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...2021-12-1126 min
The Qualitalks PodcastThings That Have to Change in GMP to Drive Success [Jerry Chapman]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...2021-10-2023 min
The Qualitalks PodcastHow to Build a Successful Career in the Pharma of Tomorrow [Megann Löffler]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 ser...2021-10-0622 min
The Qualitalks PodcastFDA Insider Secrets - All You Need To Know To Avoid A Warning Letter [Luis Charles Chavarría]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...2021-09-2242 min
The Qualitalks PodcastHow 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 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...2021-09-0831 min
The Qualitalks PodcastWhat are CMOs and what are they good for (Part 1) [Kurt In Albon from Lonza]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, i...2021-08-2540 min
The Qualitalks PodcastHow To Use LinkedIn To Grow a Powerful Business NetworkIn 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...2021-08-2552 min
The Qualitalks PodcastLeadership Lessons From the Head of Global Information Quality at LonzaIn 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.
Who 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 over 25 years and holds leading-edge expertise in data integrity, pharmaceutical...2021-08-1843 min
The Qualitalks PodcastWhat 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 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.
...2021-08-1138 min
The Qualitalks PodcastThe Golden Rules of Hosting an Audit [Àngels Llarch]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.
Who's Àngels Llarch?
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 indu...2021-07-1421 minThe Qualitalks PodcastHow Artificial and Automated Intelligence Change the Pharmaceutical Landscape [Christy Mazzarisi]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...2021-05-1639 minThe Qualitalks PodcastThe Death of Quality [Yuval Shapiro]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 o...2021-05-0247 minThe Qualitalks PodcastThe Challenges of a GMP Consultant [Suzanne Studinger]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.2021-04-1145 minThe Qualitalks PodcastWhat They Don't Teach You in CSV Training [James Ainsworth]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...2021-03-0642 minThe Qualitalks PodcastUnconventional Approach to Pharmaceutical QA and GMP [Yaron Ziv]"QA is a service provider and not a slave of the regulations."
-Yaron Ziv
Yaron is a pharmacist and the Head of QA at Chemipal, a medicinal distribution service provider. He is known in his community for his unconventional QA approach, making him an exceptional industry leader.
In this podcast episode, Yaron explains the fundamental role of the QA from his point of view - a service provider and not a slave of the regulations. He describes the benefit of this approach and how QA leaders can achieve that in their organizations.
2021-01-3142 minThe Qualitalks PodcastData Integrity - Connecting the Dots [Galit Lisaey]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 Information Technology Project Manager, and Expert of 20 years.
Here are some of the points they touched during the discussion:
💡 Data life cycle and dot-connecting
💡 The human factor in data integrity
💡 Why people need to sit together and speak about risks
💡 How to use audit trail correctly
💡 How to set control points
💡 Why data integrity isn't mentioned in warning letters anymore.
2021-01-1735 minThe Qualitalks PodcastGMP Training The Right Way [Dominic Parry]GMP training is mandatory, but nobody explains how to conduct it correctly, effectively, or measure results.
Dominic Parry is the Director of Inspired Pharma, a company based in the UK specializing in GMP training. And in this podcast episode, he explains how to do all of the above and much more.
Here are some of the matters you will learn about in this episode:
💡 Presence vs. Virtual training
💡 How to improve virtual training
💡 How to keep people attentive in virtual training
💡 The advantages and disadvantages...2021-01-0348 minThe Qualitalks PodcastDigital Solutions and Commercial Success in Pharma [Davidek Herron]Davidek Herron is the Head of Global Digital Platforms & Operations at Teva Pharmaceuticals.
His mission in Teva is to leverage digital technologies to get medicines to patients in need in a more efficient, quick, and safe way.
In this podcast episode, Davidek talks to Yan Kugel about the importance of digital services for pharmaceutical companies and explains why their success depends on digitalization.
He also gives precious tips on how to achieve successful digitalization in any company.
Here are some of the topics you will hear about in th...2020-12-2041 minThe Qualitalks PodcastHow To Qualify Your Equipment 101 [Vlatko Kantardjioski]In this podcast episode, Vlatko Kantardjioski gives an amazing overview of equipment qualification in the pharmaceutical industry.
Vlatko is a Quality Assurance Specialist and served in leading positions in various equipment qualification projects.
Vlatko gives many expert tips and explains in details each stage in a pharmaceutical qualification:
- User Requirement Specifications
- Design Qualification (DQ)
- SAT (Site Acceptance Test)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Watch the full video episode on podcast.quaistery.com.
2020-12-061h 12The Qualitalks PodcastWhat Are Cloud Services and How to Validate Them [Borislav Milev]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 cloud-based, and pharma is not any different. Cloud computing holds in itself immense benefits but introduces new challenges in data integrity and validation.
Borislav Milev is a CSV expert specializing in cloud computing. In this episode, Borislav will make everything about cloud computing much clearer.
Here are some of the things you will learn about, listening to, or watching this episode:
What Are...2020-11-2255 minThe Qualitalks PodcastHow to Deal With Risk in Pharma [Alex Hall]Risk management is a crucial part of the pharmaceutical quality management system. Unfortunately, many companies don't get it right and don't understand how to use ICH Q9 correctly.
In this podcast episode, Alex hall explains the right way to approach risk and which tools to use.
Here are some of the discussed topics:
💡 How to use ICH9 appropriately
💡 Tools to identify risks
💡 The first steps in any risk Management
💡 How to design your FMEA scoring system
💡 What is ALARP and how to use it in risk...2020-11-0847 minThe Qualitalks PodcastHow To Validate Your Computerized Systems [Daniel Milek]Computer system validation (CSV) is more crucial now than ever. The reason for that is the digital transformation that pharma companies undergo in recent years. Additionally, with time, equipment, and software become obsolete. Thus, you need to replace it or update the software validated by the current GMP standards.
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.
Here are some of the topics you will learn about, listening or watching this podcast episode:
💡 The Stages of a Suc...2020-10-251h 13The Qualitalks PodcastHow to Successfully Deal With Deviations [Paul Palmer]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 part of the QMS, and one has to deal with them with care.
Not doing so can get you in trouble with regulators very quickly. In this podcast episode, Yan Kugel interviewed Paul Palmer on how to deal successfully with deviations.
Here are some of the covered topics:
💡What Types of Deviations Are There?
💡What Is the Best Process to Deal With Deviations?
💡Thi...2020-10-1151 minThe Qualitalks PodcastWhat Is the Role of the Pharma Consultant and How to Become One [Thomas McMann]In this episode of The Qualitalks Podcast, Yan Kugel interviewed Thomas McMann about the role of Contractors & Consultants in the pharmaceutical industry.
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, but want a change in pace or just had enough of organizational politics.
Thomas is head of contacts at EPM Scientific Switzerland, and during the podcast, he addresses the following topics:
Here are some of the things Thomas...2020-10-041h 07The Qualitalks PodcastThis Is How AI Will Help You Conduct an Audit [CALIDAD AI]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 changing how GMP inspectors will conduct their audits.
Here are some of the things that you will learn about in the podcast:
💡 Why Auditors Need Electronic Help
💡 Why It Is the Right Time for Pharma to Digitize
💡 How AI Can Help You During an Audit
💡 What Really Stops Pharma From Digitalizing?
💡 The Cost of Not Spending on Quality Is H...2020-09-271h 02The Qualitalks PodcastHow to Prepare Well for Regulatory Audits [Paul Palmer]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 turn the tides around and save you from critical findings.
In this episode, I've interviewed Paul Palmer on how to prepare correctly for a regulatory audit. Paul has been in the Pharmaceutical industry since 1986. He is a QP, a consultant, and a business advisor.
Here are some of the things, that you will learn about in the podcast:
💡 The Benefits of Preparing Well for an Audit
💡...2020-09-201h 07The Qualitalks PodcastWho Are Qualifyze and What Is Their Mission?At Qualistery, we love talking to innovators within the pharmaceutical world. In this episode, Yan Kugel interviewed Florian Hildebrand and Carla Peraferrer.
Florian is the CEO, and Carla is the Head of Quality at Qualifyze (Formally ChemSquare), a start-up that wants to change the way you conduct audits and qualify your suppliers. They provide auditing services across the world and believe that the future of supplier qualification lies within shared collective knowledge.
Here are some of the discussed topics:
💡 Who are Qualifyze and what is their mission?
💡 Why companies should share their a...2020-09-1339 minThe Qualitalks PodcastWhy Data Integrity Is More Important Than Ever [Daniel Milek]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 Data Integrity expert, explains what data integrity is and how to maintain it correctly.
Here are some of the discussed topics:
💡Why Data Integrity Is More Important Now Than Ever
💡What Is the Definition of Data Integrity?
💡What Are the Main Causes of Data Integrity Non-Compliance?
💡Who Are the Best People to Validate a Software?
💡What Are the Departments...2020-09-061h 11The Qualitalks PodcastHow to Combat the Two Major Deficiencies in Pharma [Yogesh Krishan Davé]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 this long time, Yogesh has encountered many deficiencies from which most pharma companies suffer.
In this podcast, Yogesh has addressed deficiencies in two systems and explained how to tackle them:
1. Training
2. Deviations and CAPA handling
Here are some of the things that you will learn about in the podcast:
💡 Training - One of the Biggest Deficiencies in the Pharma Industry
💡 How to...2020-08-3047 minThe Qualitalks PodcastFinding New Qualified Suppliers Doesn't Have to Be Hard [Ammar Badwy]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 founded Pharmaoffer, a virtual marketplace that allows pharma companies to find qualified suppliers quickly and easily.
Here are some of the things, you will learn about in the podcast:
💡What is Pharmaoffer, and What Do They Offer?
💡Ammar's Journey from Cleanroom Repackaging to CEO
💡Why Finding New Qualified Suppliers Doesn't Have to Be Hard
💡The Future of the Digit...2020-08-231h 10The Qualitalks PodcastWhen You Deal With Risk, Don't Be a Firefighter! [Alex Hall]In this episode of the Qualitalks Podcast, Alex Hall and Yan Kugel discussed Risk Management in the pharmaceutical industry.
Risk Management is a critical topic that is, unfortunately, misunderstood by many pharmaceutical companies. Many take the reactive approach instead of the proactive one, which can cause them a lot of money and risk customer lives. Any decision–making process about risks to product quality involves risk management to a greater or lesser extent.
Here are some of the things that we can learn in the pharma industry about Risk Management:
1. What is the de...2020-08-1632 minThe Qualitalks PodcastHow to Choose and Implement the Right eQMS for Your Company [Doron Sitbon]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 simple thing as it is a critical change for the quality system.
So why should you go through it and how to do it correctly?
In this episode, my guest is Doron Sitbon, the CEO of Dot Compliance, a company that provides an eQMS solution for pharma, and he is going to answer those questions and much more.
Here are s...2020-08-0959 minThe Qualitalks PodcastHow To Build a Successful Career in Pharma [Matthew Lancaster]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 with your job, Matthew Lancaster shares valuables information that will help you navigate this challenging industry and maximize your career achievements.
Matthew is the Director of Quality & Regulatory recruitment at Life Science People.
Here are some of the topics Matthew Lancaster and Yan Kugel discussed in this episode:
💡What is the main reason people fail at job interviews
💡Which are the hott...2020-08-0252 minThe Qualitalks PodcastHow To Successfully Conduct and Document an Audit [Jennifer Kussauer]In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor.
Jennifer talks and gives practical advice on how to perform a successful supplier or internal audit from start to finish.
Here are some of the topics we covered in our talk:
💡01 Secrets to a Successful Audit Opening Meeting
💡02 Here Is When Repeated Deviations Are Acceptable
💡03 Why Time Good Time Management Skill Is Important for Auditors
💡04 Here Are the Most Common Mistakes That Companies Do-
💡05 Here Is an Important...2020-07-261h 01The Qualitalks PodcastHow to Prepare for an Audit as a GxP InspectorIn this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor.
Here are some of the topics we covered in our talk:
✅The Art Behind Being a Great Auditor
✅The Biggest Challenges of an Auditor
✅Why Companies Should Be Here Is Why Companies Should Be Happy to Be Audited
✅The Best Thing About Auditing
✅Why the Opening Is So Important for a Successful Audit
✅Knowing the Scope Is the Foundation of the Audit
✅The Most Common Mistakes of...2020-07-1936 minThe Qualitalks PodcastHow To Design Aseptic Manufacturing For Best ComplianceThe 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 manufacturing with high quality in mind.
In this episode, Ashwani Tripath, head of compliance at Alembic Pharmaceuticals, explains what’s important to take into consideration when designing new aseptic manufacturing.
Here are some of the things you will learn from watching or listening to the episode:
How to design a cleanroom
Risk assessment for newly designed cleanrooms
How to deal with unexpected deviations in a...2020-07-0541 minThe Qualitalks PodcastHow Good Headhunters Can Benefit Your Career (Part 1)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, having the right headhunter on your side can be highly advantageous.
Yet, not every headhunter is an excellent recruitment consultant. Dealing with the bad weeds can waste you a lot of time, leading to nothing, but dealing with a good one, can land you the gig of your dreams.
Matthew Lancaster is Head of Quality & Regulatory Pharma recruitment at EPM scientific. And in this podcast...2020-06-2148 minThe Qualitalks PodcastHow to Build a Successful Career in Pharma With Any EducationBuilding 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 for knowledge.
Jennifer Kussauer studied communication. Nonetheless, she built a fantastic pharma career and functioned as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant.
In this podcast episode shares how she managed to build a great career without scientific education. We also dive into the fascinating world of GXP audits.
2020-06-0722 minThe Qualitalks PodcastWhy You Should Become a GMP Auditor and How to Do ItToday, 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 this podcast, featuring Shoab Malek, you will have a clear idea about the role of GMP Auditor, how to become a one, the challenges, tips, and much more.
Shoab Malek is an experienced & professional Pharmaceutical Consultant and GMP Auditor. He has faced many regulatory audits, which include USFDA, EU-GMP, PICs, UL Registrar LLC (USA), and 100+ vendor audits across India, China & Egypt.2020-05-3140 minThe Qualitalks PodcastThe Secrets to Success With Chinese Suppliers [Oliver Rhode]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 lot to consider when sourcing from China. But you have to do a lot of homework.
Oliver Rhode is the CEO of XENOPS Chemicals and an expert on raw material sourcing from China for the pharma industry. In this episode, he shares his secrets to success in finding the right suppliers in China.
Watch the video on qualistery.com2020-05-2546 minThe Qualitalks PodcastEssential Time Management Tips for Pharma [Paul Palmer]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.
In this episode, Yan Kugel talked to Paul Palmer about time management tools and methods, which can help people complete their tasks much more efficiently and promptly.
Watch the video on www.qualistery.com from May 18th. 2020-05-1752 minThe Qualitalks PodcastMedicinal Combination Products - Dr. Michael DruesIn 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 regulatory affairs.
Listening to the podcast and reading the article, you will learn:
What is a combination product?
What are some examples of combination products?
What are the roles of the Office of Combination Products?
How are combination products assigned for review?
What types of marketing applications are required for a combination product?
How are adverse events reported for combination products?
...2020-05-101h 00The Qualitalks PodcastCovid-19: Critical Quality Measures for Pharmaceutical ProductionDue 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. Some of that include:
Shortage of raw materials
Personnel deficiency
Export bans
Severe financial damage
All those obstacles lead to a unique manufacturing environment, which may lead to quality deficiencies.
During their talk, Hitendrakumar Shah, the CEO of NADH+ GXP Compliance Services, shared with Yan Kugel his suggestions on how to avoid quality issues during manufacturing, throughout that particular time.
You can watch the podcast...2020-05-0332 minThe Qualitalks PodcastValidation - Pharma vs Medical DevicesIn this episode, Yan Kugel talks to José Sergio Ávila, a validation, and sterilization specialist, about validation activities in the pharmaceutical and medical devices industries.
We covered several topics with Sergio:
EtO sterilization
Importance of purified water systems and validation challenges
Validation of medical devices and the differences to pharmaceutical validation
How to stay current with the new regulation in the quickly developing field of validation
Biggest mistakes people do when they perform validations
The Key for successful validations
Tips for becoming experts in the field
Watch the video an...2020-04-2631 minThe Qualitalks PodcastCOVID-19 and the Drug Shortage From IndiaShoab Malek is a pharmaceutical consultant and a GMP auditor, located in India. He talked to Yan Kugel about the big challenges that India faces because of COVID-19. Being the biggest generic pharmaceutical exporter in the world, it may influence the whole world. The prices in India for many drugs have already doubled or tripled, for many reasons:
Raw material shortage
Packaging material shortage
Shortage of skilled workers
Not enough storage places for finished goods
The supply chain to the rest of the world has completely stopped
The videocast is available on
www.qualistery.com2020-04-1931 minThe Qualitalks PodcastThe Role of a Qualified Person (QP) in EuropeIn this episode of the Qualitalks Podcast, Alex Hall and I discuss the most crucial role of the Qualified Person in the pharmaceutical industry.
Listening to the podcats and reading the article, you will learn:
About the role of the Qualified Person (QP) in the European Union
The difference between a QP and a quality manager
Who should consider becoming a QP
The legal requirements for becoming a QP
What soft skills are required to become a QP
Tips for success in becoming a QP
Watch the video:
www.qualistery.com2020-04-1236 minThe Qualitalks PodcastQuality Assurance Philosophy with Paul PalmerPaul Palmer and I 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, time, and money. But it is not too late for any company to change that.
In the podcast/article, you will learn:
What QA philosophy is
What benefits QA philosophy holds
How to implement the QA Philosophy across the organization
What mistakes to avoid when looking at trend analysis
Why and how to choose consultants to support you
2020-04-0554 minThe Qualitalks PodcastWelcome to the Qualitalks PodcastThe pharmaceutical industry is a fascinating and complex field. Countless people work hard to release a quality product to the market. In the Qualitalks podcast, we talk to experts, leaders, and innovators who tell us how they do it! We talk about GMP, business, quality, and everyday life in the pharmaceutical industry.2020-03-1500 min