Setting Specifications AND Stability Testing AND post-conference session Stability Studies
Vienna, Austria
Course No 16383
Costs
This Training Course has unfortunately already taken place. However, if you are interested in this seminar, we will be happy to inform you about the new date or about further offers on the topic. Simply use the following contact form to send us your request.
* payable by credit card
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
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
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others