Setting Specifications AND Stability Testing AND post-conference session Stability Studies
Vienna, Austria
Course No 16383
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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
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- Microbiology
- Regulatory Affairs
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- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
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- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity