Setting Specifications AND Stability Testing AND post-conference session Stability Studies

28 Nov - 1 Dec 2017, Vienna, Austria

Course No. 16383



Setting Specifications and Acceptance Criteria

Dr Thomas Fürst, SANOFI, Biberach, Germany

Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany

Dr Cornelia Nopitsch-Mai, Bonn, Germany

Dr Bettina Pahlen, Quality x Pharma Consulting GmbH, Germany

Dr Thomas Uhlich, Bayer Pharma, Germany

Stability Testing for Drug Substances and Drug Products

Dr Thomas Fürst, SANOFI, Biberach, Germany

Dr Wolfgang Grimm, Germany

Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany

Dr Jordi Ruiz-Combalia, Audit GMP, Spain

Dr Thomas Uhlich, Bayer Pharma

Post-Conference Session:

Dr Raphael Bar, BR Consulting, Israel


Setting Specifications and Acceptance Criteria

  • Regulatory Requirements for Specifications (ICH Q6A)
  • Regulatory Requirements for Specifications of Biotech Products/
  • Well-characterised Biologicals (ICH Q6B, etc.)
  • Principles for Setting of Release and Shelf-life
  • Specifications throughout Development
  • Organic Impurities, Degradation Products and Genotoxic Impurities
  • Rational Development and Justification of API Specifications, Drug Products Specifications, Biological Drug Substances and Products focussing on Monoclonal Antibodies (mAbs)
  • Specifications for Specific Drug Products
  • Specifications for Excipients and Container Closure Systems (EU/US) including important aspects such as latest news on functionality
  • testing (EP, USP) and GMP for excipients

Stability Testing for Drug Substances and Drug Products

  • Stability testing from early development to product launch
  • Stability testing strategies for Drug Products
  • Essential hints for writing the stability part in the CTD
  • Stability Studies after approval (EU/US)
  • Evaluation of stability results – Statistical Considerations

Post-Conference Session Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals

  • Stability programs and stress testing – a regulatory overview
  • Qualification of shipment and temperature monitoring
  • World climatic zones and Mean Kinetic Temperature
  • Storage label statements in the EU and the US
  • Studies at different temperatures and conditions
  • Investigation and evaluation of excursions and responsibility issues


This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more

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