Richard M. Bonner, formerly Eli Lilly and Company Limited, UK
Anthony Storey, Pfizer, UK
Francois Vandeweyer, Janssen Pharmaceutica, Belgium
Dipl.-Psych. Peter C. Zimmermann, Iskom, Germany
In this training course you will have the opportunity to prepare and conduct an audit at different departments of a fictitious API Manufacturing plant. According to a case study you are confronted with specific situations in that company where you have to act as auditors in an appropriate way. You will learn
- how to apply your technical and communication skills
- how to focus on specific API related aspects
- how to deal with possible fraud, cultural and language differences e.g. in overseas audits
The illustration of communication aspects will be supported by video feedback.
The basic documents for this training course will be the ICH Q7 Guideline and APIC/CEFIC‘s „How-to-Do“ document, an interpretation of the ICH Q7 requirements.