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Genau Talks is a series of videos that focuses on questions and tendencies within compliance. We would like to share these with you.

Our CEO, Henrik Johanning, looks at current subjects within different professional-technical disciplines and discusses them with specialists. As professionals, we also need to shed light on these subjects in order to be able to do our job perfectly when we collaborate with our clients. Since we know that these subjects are just as current and relevant for others, we want to share this knowledge with you.

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Genau Shares

FDA-483 observations and warning letter citations 2019 – 2020

John Lee, Video 2 of 9

FDA Inspections during COVID-19 pandemic

John Lee, Video 1 of 9

Covid-19 also poses challenges to Life Science, especially within GMP-regulated environments

E.g., how do you comply with the regulatory requirements within...

Kvalitet og tillid sat i system

For vores medarbejdere og klienter er det selvfølgelig...

Topledelser sætter kvalitet øverst på agendaen

Kvalitet og compliance var nok ikke tidligere et begreb som...

Virtual, quick and efficient GxP Consultancy

Still connected and supportive though on a safe distance and...

Genau Talks Video and Podcasts

Genau Talks Podcast

#1 Is your company in compliance?

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

#2 The authorities have gained an increased focus on data integrity

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.

Free E-book about Data Integrity

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If there are subjects that you would like us to examine, you are welcome to write to us.
We respond to all enquiries.

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