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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 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
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Preparing yourself for the FDA audit
Preparing yourself for the FDA audit
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Risk-assessments, design qualification and audit trail
Risk-assessments, design qualification and audit trail
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Recommendations working with Computerised Systems
Recommendations working with Computerised Systems
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Current regulations within EU GMP on computer systems validation
Current regulations within EU GMP on computer systems validation
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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
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The future within EMEA on validation of computer systems.
The future within EMEA on validation of computer systems
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IT and QA are getting closer
IT and QA are getting closer
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FDA GMP and EU GMP on hybrid systems
FDA GMP and EU GMP on hybrid systems
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Main trends within validation in general.
Main trends within validation in general
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Computer Systems Validation and Part 11.
Computer Systems Validation and Part 11
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Making correct and practical best use of design qualification
Making correct and practical best use of design qualification
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Wrong resources and attention put into wrong quality programs
Wrong resources and attention put into wrong quality programs
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John Lee talks about data integrity, statistics and trends.
John Lee on data integrity, statistics and trends

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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