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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 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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