"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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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, and that 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...

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...

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...

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...

In 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...

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 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...

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...

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 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...

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 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,...