Karriere
Kom med på holdet

Vi deler gerne ud af vores viden

Let's share

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.

OpenGraphBillede: 

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

Pages

Genau Talks Video and Podcasts

play Genau & More video
Michael Weng om IT systemer
Michael Weng om IT systemer
play Genau & More video
Michael Weng om Data Integrity
Michael Weng om Data Integrity
play Genau & More video
Michael Weng om inspektionsparathed og anbefalinger
Michael Weng om inspektionsparathed og anbefalinger
play Genau & More video
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

Pages

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.

Tilmeld dig HER og få besked, når der kommer nye Genau Talks videoer og podcasts

Download Gratis e-bog om Data Integrity

Læs mere

Indsend dit forslag til emne

Hvis der er emner, du ønsker at vi skal tage op, så er du velkommen til at skrive til os.
Vi besvarer alle henvendelser.