Setting Specifications AND Stability Testing AND post-conference session Stability Studies
28 Nov - 1 Dec 2017, Vienna, Austria
Course No. 16383
Speakers
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
Programme
Setting Specifications and Acceptance Criteria
Highlights:
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
Highlights:
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
Highlights:
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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Seminar Programme as PDF