Live Online Conference: Rapid Microbiological Methods and Mycosplasma Testing - Part of PharmaLab 2020

Live Online Conference: Rapid Microbiological Methods and Mycosplasma Testing - Part of PharmaLab 2020

Course No 200035


Costs

This Training Course has unfortunately already taken place. Therefore, registration is not possible any more. However, recordings are available for many courses, which you can order and view at any time. You will find these recordings in a list sorted by topic. Of course you can also use the following contact form to send us your request.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

 

Programme

09.00 - 09.30 h
Introduction and Organisationals

 

09.00 - 09.45 h
Key Note: RTRT: A Reality Check in the Small and Large Molecule World
Dr Lorenz Liesum, F. Hoffmann-La Roche

 

09.45 – 10.30 h - Validation of Alternative Methods: the Perspective from the European Pharmacopoeia
Emmanuelle Charton, EDQM

 

10.30 – 11.00 h - Development and Validation of a Rapid Sterility Test using BacT/ALERT Dual T
Dr Marja Claassen, MSD

 

11.00 – 11.15 h Break

 

11.15 – 11.45 h - Validation and Implementation of an Automated Colony Counter for Product Bioburden Testing
Dr Sven M. Deutschmann, Roche Diagnostics

 

11.45– 12.15 h - Non-inferiority Testing for RMM Validation: Two use Cases
Dr Viviane Grunert da Fonseca, Roche Diagnostics

 

12.15 – 12.45 h - Questions and Answers

 

12.45 – 13.45 h Break

 

13.45 – 14.15 h - From Visual Counting to Automation of Water Monitoring with the Growth Direct
Johannes Oberdörfer, Boehringer Ingelheim

 

14.15 – 14.45 h - Validating a Rapid Sterility Test: Practical Strategies to Ensure Regulatory Compliance
Dr Michael Miller, Microbiology Consultants

 

14.45 – 15.15 h - Rapid Microbial Test for Short Shelf Life Pharmaceuticals
Kai Nesemann, Sartorius

 

15.15 – 15.30 h Break

 

15.30 – 15.45 h - A Real-time PCR Assay designed to fulfill Mycoplasma Detection Regulatory Requirements
Darren Bauer, Thermo Fisher Scientific

 

15.45 – 16.15 h - Making the Switch: the Evaluation, Implementation and Validation of bringing Rapid Mycoplasma Testing in-house to expedite Lot Release of Recombinant Protein Product 
Dr Kent Persson, Octapharma

 

16.15 – 17.00 h - Questions and Answers

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