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Genau Talks er en række videoer og podcasts, der stiller skarpt på spørgsmål og tendenser indenfor compliance. Dem vil vi gerne dele med dig.

Vores CEO, Henrik Johanning, tager højaktuelle emner op indenfor forskellige fagtekniske områder og drøfter dem med specialister. Disse emner har vi selv brug for at få belyst for at kunne udføre vores opgaver til perfektion, når vi samarbejder med vores klienter. Da vi ved, at disse emner er ligeså aktuelle og relevante for andre, vil vi gerne dele denne viden med jer.

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Genau Shares

Showstopper GMP Violations. FDA Drug GMP

John Lee, Video 3 of 9

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 Data Integrity in your company in connection with...

Kvalitet og tillid sat i system

For vores medarbejdere og klienter er det selvfølgelig afgørende, at de kan have tillid til os som arbejdsgiver og tæt...

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Genau Talks Video and Podcasts

play Genau & More video
Recommendations working with Computerised Systems
Recommendations working with Computerised Systems
play Genau & More video
Current regulations within EU GMP on computer systems validation
Current regulations within EU GMP on computer systems validation
play Genau & More video
Anna Lundén talks about tendencies and developments to be found in observations and warning letters
Anna Lundén on the tendencies and developments in observations and warning letters
play Genau & More video
The future within EMEA on validation of computer systems.
The future within EMEA on validation of computer systems
play Genau & More video
IT and QA are getting closer
IT and QA are getting closer
play Genau & More video
FDA GMP and EU GMP on hybrid systems
FDA GMP and EU GMP on hybrid systems

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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.

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