GMP Lead Auditor
GMP Lead Auditor

Course Description

This course gives you a 2-day full training about GMP audits. You will not only get the basics about the jobs and tasks on both sides of a GMP auditors (as the auditor and as the auditee), but you will also face several examples directly from practice. These examples will be presented to you by the trainer and then you have plenty of time to discuss them in small groups. How would you react? What is the best behavior? What are the best follow-ups. With this interactive course you will not only broaden your experiences, but you will also have a very interactive exchange with the participants and learn about different opinions and different strategies.

This course also covers the topics risk orientated planning, problem solving strategies, the fast and effective execution of audits, the classification of audit findings and communication strategies for audits.

  • Regulatory background (EU-GMP Guideline, CFR, ICH, EMA, FDA guidance and the PIC/S)
  • ISO19011
  • Practical examples from real audits
  • Risk oriented planning
  • Audit plans, check lists and reports
  • Classification of audit findings
  • CAPA-plans
  • Management of difficult situations
  • Experience exchange
  • Cultural differences
  • Problem solving strategies
  • Communication strategies for audits
  • Experience exchange with the other participants on a multicultural platform
  • Examples from real audits with workshops and role play
  • Audit finding classification systems
  • Smart strategies for the planning and execution of audits
  • Strategies for problem solving
  • Communication strategies
  • Trouble shooting
  • Knowledge tests
  • Workshops
  • Break-Out sessions with real audit examples

GMP Lead Auditor

19 - 20 March 2024, Live Online Training
€1.650,00
Dr. Felix Kern

Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.

START TIMES

9:00 AM Vienna time

8:00 AM London time

4:00 AM New York time

1:00 AM Los Angeles time

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Course Description

This course gives you a 2-day full training about GMP audits. You will not only get the basics about the jobs and tasks on both sides of a GMP auditors (as the auditor and as the auditee), but you will also face several examples directly from practice. These examples will be presented to you by the trainer and then you have plenty of time to discuss them in small groups. How would you react? What is the best behavior? What are the best follow-ups. With this interactive course you will not only broaden your experiences, but you will also have a very interactive exchange with the participants and learn about different opinions and different strategies.

This course also covers the topics risk orientated planning, problem solving strategies, the fast and effective execution of audits, the classification of audit findings and communication strategies for audits.

  • Regulatory background (EU-GMP Guideline, CFR, ICH, EMA, FDA guidance and the PIC/S)
  • ISO19011
  • Practical examples from real audits
  • Risk oriented planning
  • Audit plans, check lists and reports
  • Classification of audit findings
  • CAPA-plans
  • Management of difficult situations
  • Experience exchange
  • Cultural differences
  • Problem solving strategies
  • Communication strategies for audits
  • Experience exchange with the other participants on a multicultural platform
  • Examples from real audits with workshops and role play
  • Audit finding classification systems
  • Smart strategies for the planning and execution of audits
  • Strategies for problem solving
  • Communication strategies
  • Trouble shooting
  • Knowledge tests
  • Workshops
  • Break-Out sessions with real audit examples

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

GMP Lead Auditor

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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