This episode is the second of a series of Podcasts where our CEO Henrik Johanning discusses topics with different Life Science specialists. In this episode, Henrik Johanning has invited counselor Michael Weng, who is a specialist within Computer System Validation (CSV) and Data Integrity, to a talk where they include: Data Inspection Readiness IT-systems And why it is so important to map the data flow to be able to make the necessary risk assessment. The whole talk is in Danish. 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

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