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

11 November 2020: EUR 590,--

(All prices excl. VAT)

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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