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