ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation

ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation

Berlin, Germany

Course No 17590

 

Costs

ECA-Member: EUR 1790,--
Non ECA Member: EUR 1990,--
EU/GMP Inspectorates: EUR 995,--
APIC Member Discount: EUR 1890,--

(All prices excl. VAT)

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

Speakers

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

Objectives

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.

Target Group

These education courses are designed for all persons involved in the manufacture of APIs (either chemically or by cell culture/fermentation) especially for persons from production, quality control, quality assurance , technical and regulatory affairs departments as well as for Qualified Persons and Auditors. We are also addressing interested parties from engineering companies, from the pharmaceutical industry and GMP inspectorates.

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