ECA - ICH Q7 Auditor Training Course

ECA - ICH Q7 Auditor Training Course

Berlin, Germany

Course No 17591



ECA-Member: EUR 2090,--
Non ECA Member: EUR 2290,--
EU/GMP Inspectorates: EUR 1145,--
APIC Member Discount: EUR 2190,--

(All prices excl. VAT)

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


Ralf Gengenbach, gempex, Germany
Andy Bailey, ViruSure, Austria
Markus Dathe, F. Hoffmann-La Roche, Switzerland
Paul Lopolito, Steris Corporation, USA
Peter Mungenast, Merck KGaA, Germany
Rob Slobbe, Philips Image Guided Therapies, The Netherlands
Paul Stockbridge, Stockbridge BioPharm Consulting, UK
Francois Vandeweyer, VDWcGMP Consultancy, Belgium
Peter C. Zimmermann, Iskom, Germany


These education courses have been developed to provide an excellent knowledge of the requirements laid down in ICH Q7. The contents of the guideline will be explained step by step and practical advices will be given on how to fulfil the requirements of ICH Q7. You will also get to know the key principles of risk management, quality systems and development and manufacture of APIs as they are laid down in ICH Q9, Q10, Q11 and the ICH Q7 Q&A Document. For example you will learn
  • at which stage of production GMP compliance is to be applied,
  • how to comply with GMP hot topics like process validation, reprocessing/reworking, equipment qualification, change control, failure investigation etc.,
  • how to use a risk-based approach within the concept of supplier qualification,
  • how to link material attributes and process parameters to drug substances CQAs,
  • what has to be considered in order to be prepared for a GMP inspection.


Conducting an audit – tools and technical aspects

CEFIC / APIC’s activities and Working Groups – QP demands for an API audit – APIC’s Third Party Audit programme
  • CEFIC / APIC Quality Working Group
  • EU Legislation and Advice on GMP Status of Active Substances
  • Third Party Audit Principles
  • The APIC Audit Programme
  • Auditor Certification
  • Phases of the APIC Audit Programme
  • Contracts between Auditors and Auditees
  • Audit Dos and Don’ts
  • Advance preparations for a successful audit
  • Performing the audit
  • Closing meeting
  • Audit report


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