The Qualitalks Podcast

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 dig...

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 Qualific...

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...

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 i...

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 Lt...

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 cov...

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 organiza...

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 Ca...

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 busines...

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 believ...

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 Cause...

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...

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...

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 p...

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...

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 D...

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...

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 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...

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, l...

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, G...

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 Phar...

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...

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...

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 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 th...