Live Online Conference: Endotoxin and Pyrogen Testing - Part of PharmaLab 2020
Course No 200034
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.
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Programme
Programme - 10 November 2020
09.00 - 09.30 h
Introduction and Organisationals
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
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
Speaker invited
11.15 – 11.45 h - Evaluation of rFC
Speaker Boehringer Ingelheim invited
Speaker Boehringer Ingelheim invited
11.45 – 12.15 h - The Changing BET Landscape and the Recombinant Alternative
Veronika Wills, Associates of Cape Cod.
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
Nicola Reid, Charles River Laboratories
14.15 – 14.45 h - Symbols of Infection
Kevin Williams, BioMerieux
Kevin Williams, BioMerieux
14.45 – 15.15 h - Impact of Sample Preparation on Endotoxin Detection
Speaker Invited
Speaker Invited
15.15 – 15.30 h Break
15.30 – 15.45 h - Masking of Endotoxin during Sample Hold Time
René Ørving, Novo Nordisk
René Ørving, Novo Nordisk
15.45 – 16.15 h - FDA's Thinking on Current Developments in Endotoxin and Pyrogen Testing
Speaker FDA (invited)
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
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
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
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
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
Pyrogen Detection on Cellular Prepartions and other Short Shelf Life Pharmaceuticals
Stefan Gärtner, Labor LS
12.15 – 12.45 h
Questions and Answers
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
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
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
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
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
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
Questions and Answers
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