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Course No 7675

Auditing a fictitious API Facility - A Workshop Case Study for API Lead Auditors

13-15 March 2013, Berlin, Germany


Costs:
Non-ECA Members: EUR 2.290,--
ECA Members: EUR 2.090,--
EU GMP Inspectorates: EUR 1.145,--
APIC Members (does not include ECA membership): EUR 2.190,--
(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de
Speakers
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

Objectives
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/CEFICs How-to-Do document, an interpretation of the ICH Q7 requirements.

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