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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

Preparing for an effective FDA Inspection. FDA DRUG GMP

John Lee, Video 9 of 9

Audit Trail. FDA DRUG GMP

John Lee, Video 8 of 9

Risk Assessment, FDA DRUG GMP

John Lee, Video 7 of 9

Data Integrity. FDA DRUG GMP

John Lee, Video 6 of 9

Trends. FDA Drug GMP versus EU Grug GMP

John Lee, Video 5 of 9

Novel / Recurring deficiencies causing a FDA Warning Letter.

John Lee, Video 4 of 9

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Genau Talks Video and Podcasts

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Michael Weng om IT systemer
Michael Weng om IT systemer
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Michael Weng om Data Integrity
Michael Weng om Data Integrity
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Michael Weng om inspektionsparathed og anbefalinger
Michael Weng om inspektionsparathed og anbefalinger
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FDA GMP: Compliance issues and trends
FDA GMP: Compliance issues and trends
play Genau & More video
Preparing yourself for the FDA audit
Preparing yourself for the FDA audit
play Genau & More video
Risk-assessments, design qualification and audit trail
Risk-assessments, design qualification and audit trail

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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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