GMP Compliance for Biopharmaceuticals AND Workshop GMP for ATMPs
Heidelberg, Germany
Course No 15193
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Costs
This conference already took place.If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
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 Andrea Hauser, Jose-Carreras Center, University Hospital Regensburg
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Dr Ralf Sanzenbacher, Paul-Ehrlich-Institut; German Federal Agency for Vaccines and Biomedicines
Dr Ohad Karnieli, Karnieli Ltd
Jan-Oliver Karo, PEI, German Federal
Agency for Vaccines and Biomedicines
Programme
GMP Compliance for Biopharmaceuticals
Regulatory Requirements on
Biopharmaceuticals
Validation of Analytical Methods and
Processes
Case Study: Process Transfer from
Development to Commercial Production
Quality Assurance for Biopharmaceuticals
Case Studies: Hygienic Deviations
Cleaning Validation in Biopharmaceutical
Manufacturing
Workshop GMP for ATMP
Regulatory Background – an update of recent developments – Authority’s and Stakeholders View
Inspection Experiences
GMP Implementation in Clinical Trial Applications and Manufacturing
Microbiological Safety
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity