Live Online Conference: Endotoxin and Pyrogen Testing - Part of PharmaLab 2020

Live Online Conference: Endotoxin and Pyrogen Testing -  Part of PharmaLab 2020

Course No 200034


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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.

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Programme

 

Programme - 10 November 2020



09.00 - 09.30 h
Introduction and Organisationals



09.30 - 10.15 h
Key Note: Current European Pharmacopoeia Developments, with a Focus on Microbiology
Dr Emmanuelle Charton, EDQM, Head of Divison B




10.15 – 10.45 h Break

 

10.45 – 11.15 h - Invention of rFC
Speaker invited

 

11.15 – 11.45 h - Evaluation of rFC
Speaker Boehringer Ingelheim invited

 

11.45 – 12.15 h - The Changing BET Landscape and the Recombinant Alternative
Veronika Wills, Associates of Cape Cod.

 

12.15 – 12.45 h - Questions and Answers

 

12.45 – 13.45 h Break

 

13.45 – 14.15 h - Data as clean as Water: The Criticality of Detecting Relevant Endotoxins in Global Pharmaceutical Water Samples
Nicola Reid, Charles River Laboratories

 

14.15 – 14.45 h - Symbols of Infection
Kevin Williams, BioMerieux

 

14.45 – 15.15 h - Impact of Sample Preparation on Endotoxin Detection
Speaker Invited

 

15.15 – 15.30 h Break

 

15.30 – 15.45 h - Masking of Endotoxin during Sample Hold Time
René Ørving, Novo Nordisk

 

15.45 – 16.15 h - FDA's Thinking on Current Developments in Endotoxin and Pyrogen Testing
Speaker FDA (invited)

 

16.15 – 17.00 h - Questions and Answers




Programme - 11 November 2020


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
Overcoming Technical Issues with Assays to sssess Innate Immune Response Modulating Impurities
Speaker FDA invited

10.30 – 11.00 h
The Endotoxin Hypothesis of Neurodegeneration
Professor Guy C. Brown, Department of Biochemistry, University of Cambridge

11.00 – 11.15 h Break

11.15 – 11.45 h
Use of Monocyte Activation Test for Evaluation of Pyrogenicity associated with typical Environmental Contaminants
Dr. Anja Fritsch, Confarma

11.45– 12.15 h
Pyrogen Detection on Cellular Prepartions and other Short Shelf Life Pharmaceuticals
Stefan Gärtner, Labor LS

12.15 – 12.45 h
Questions and Answers

12.45 – 13.45 h Break

13.45 – 14.15 h
Determination of Pyrogens from Medical Devices/MAT Multiplexing
Dr Wolfgang Rudy, Tentamedix

14.15 – 14.45 h
Using the Monocyte Activation Test to determine the Pyrogenicity of an OMV Vaccine
Dr Marijke Molenaar-de Backer, Sanquin

14.45 – 15.15 h
The Monocyte Activation Test (MAT): The Road forward for Pyrogen Testing
Shabnam Solati, CTL-MAT

15.15 – 15.30 h Break

15.30 – 16.00 h
Indutrials Experiences with MAT
Speaker invited

16.00 – 16.30 h
How to handle Endotoxin OOS, OOT and Atypic Results – the ECA Guide on Microbiologival Deviation Chapter 2
Jordi Iglesias, Charles River Laboratories

16.30 – 17.00 h
Questions and Answers

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