This episode is the first in a series of Podcasts where our CEO Henrik Johanning discusses topics with different Life Science specialists.

In this episode, Henrik Johanning has invited former FDA inspector John Lee to a talk where they include:

• FDA GMP: Compliance issues and trends


• Risk-assessment, design qualification and audit trail


• Preparing yourself for the FDA audit

The first 00:50 seconds is an intro in Danish. The talk is in English.

If you would like to listen to more topics with our CEO Henrik Johanning and a number of other specialists, we'll share it all with you right here: Let's share knowledge

on our website with a series of Genau Talks videos and podcasts.



The different podcasts can be heard independently of each other.

You can also read more about us at: www.genauandmore.com