GMP Compliance for Biopharmaceuticals AND Workshop GMP for ATMPs

GMP  Compliance for Biopharmaceuticals AND Workshop GMP for ATMPs

Heidelberg, Germany

Course No 15193


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

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