GMP Compliance for Biopharmaceuticals
Dr Markus Fido, Vela Laboratories
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Stephan Löw, GSK
Dr Daniel Müller, GMP Inspector, German Local Government
Axel Schroeder, Concept Heidelberg
GMP for Advanced Therapy Medicinal Products (ATMP)
Dr Rainer Gnibl, Government of Upper Bavaria
Dr Andrea Hauser, Jose-Carreras Center, University Hospital Regensburg
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Jan-Oliver Karo, PEI, German Federal Agency for Vaccines and Biomedicines
Dr Ralf Sanzenbacher, Paul-Ehrlich-Institut; German Federal Agency for Vaccines and Biomedicines
Niina Taylor, Pfizer
Programm
GMP Compliance for Biopharmaceuticals
GMP Requirements Applying to Biotechnological Investigational Medicinal Products (IMPs of Clinical Phases I-III & APIs for use in IMPs)
EU regulations & guidances
Examples of national regulations
State-of-the-art manufacturing for clinical phases
GMP Guidelines for Biopharmaceuticals – a brief summary
Relevant international regulations
European biotech guidances
Recent developments & possible impacts
Development of Biopharmaceuticals - GMP and Regulatory Aspects
GMP and Regulatory Documents
Ways to Success
Interaction with Authorities (Meetings/Inspections)
Development, Qualification and Validation of Process Analytics for Biopharmaceuticals
Relevant Guidelines
Phases of Product Development / Testing
Requirements
Method Portfolio/Method Development / Method Qualification / Method Validation
GMP Inspections in Biopharmaceutical Production
Inspections of biopharmaceutical companies
Focus & discussion points during inspections
Clean room classes for biotech facilities
Open vs. closed processing
Single - vs. multi purpose equipment
Cell banking activities
Inspector’s experience, examples of observations
Case Study: Process Transfer from Development to commercial Production
Key-Aspects for EU and US
Difference between Development and Commercial Production
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