Course No 20315
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The Pre-Conference Workshop is directed to responsible personnel involved in Quality Control testing of biopharmaceuticals and biologics, e.g.:
Pitfalls and Issues on Mycoplasma Testing According to Pharmacopoeial Requirements -
A Regulator´s View on ATMPs
Jan Oliver Karo, Paul-Ehrlich Institut, German Federal Agency for Vaccines and Biomedicines
dPCR quantified Mycoplasma Standards – a New Level of Confidence
Dr Miriam Dormeyer, Sartorius
Challenges during the Validation of an Alternative Mycoplasma Detection Method
Christiana Schnitzler, Boehringer Ingelheim
Mycoplasma Testing for ATMPs: Rapid Methods and Validation Strategies
Dr Stefanie Bayer, Labor LS
Mycoplasma Detection in Complex ATMP Matrices
Dr Jonathan Hanley, Nissui Pharma Solutions
Validation of DNA Extraction Robots - The Balance between GMP Annex 11 v. Actual Best Performance
Jo Milne, Mycoplasma Experience
Recent revision proposal of Ph. Eur.-Chapter 2.6.7 "Mycoplasmas": What is proposed to be changed and why?
Dr Sven M. Deutschmann, Roche, Member of the EP Expert Group
Alternative Adventitious Agents Detection Methods in Biopharmaceuticals: A Proposal for a Structured Best Practice Approach for their Evaluation, Validation and Implementation
Dr Sven M. Deutschmann, Chair of the Phamaceutical Microbiology Working Group