Episode Archive - The Qualitalks Podcast

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, Jenni shares how she managed to build a great career without scientific education. We also dive into the fascinating world of GXP audits.

Quality Assurance

Featured

Why You Should Become a GMP Auditor and How to Do It

Shoab Malek June 1, 2020

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, EU-GMP, PICs, UL Registrar LLC (USA), and 100+ vendor audits across India, China & Egypt.

Supply Chain

Featured

The Secrets to Success With Chinese Suppliers

Oliver Rhode May 25, 2020

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.

Business

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Business

Essential Time Management in Pharma

Paul Palmer May 18, 2020

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.

Regulatory Affairs

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Medical Devices

Medicinal Combination Products

Michael Drues May 11, 2020

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. Read the full bio.

Quality Assurance

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Quality

Covid-19: Critical Quality Measures for Pharmaceutical Production

Hitendrakumar Shah May 4, 2020

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.

Validation

Quality

Validation – Pharma vs Medical Devices

José Sergio Ávila April 27, 2020

In this episode, Yan Kugel talked to José Sergio Ávila, a validation, and sterilization specialist, about validation activities in the pharmaceutical and medical devices industries.

Supply Chain

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Quality

Covid-19 – the Devastating Impact on the Indian Pharma Industry

Shoab Malek April 20, 2020

Shoab Malek is a pharmaceutical consultant and a GMP auditor, located in India. Malek 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 globe. The prices in India for many drugs have already doubled or tripled, for many reasons

Quality Assurance

Featured

The Role of the Qualified Person (QP)

Alex Hall April 13, 2020

In this episode of the Qualitalks Podcast, Alex Hall and Yan Kugel discuss the crucial role of the Qualified Person in the pharmaceutical industry. Alex also provides great tips on how to become a QP.

Quality Assurance

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Quality

Quality Assurance Philosophy

Paul Palmer April 6, 2020

Paul Palmer and Yan Kugel 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.