The Qualitalks Podcast

Due to the COVID-19 situation, governments across the world initiated lockdown and quarantines. The lockdowns have a severe impact on pharmaceutical manufacturing across the globe. 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 the...

In 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...

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 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...

In 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 Q...

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 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 organi...

The 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.