Summary
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.
Learning Objectives
- 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
Key Topics
- 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
Who should attend?
Everyone who is concerned with GxP audits, for example: GMP Auditors, QA Professionals, CMO and CLO Managers and Representatives, Manufacturing Experts, Quality Control Experts, Regulatory Affairs Managers, Validation Experts, Supply Chain Managers, Sales Representatives, IT Managers in the fields of GxP, EHS Managers.
The course is designed for beginners, advanced expert GMP auditors.
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
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.
