Mycoplasma Matters – Answers to Your Real-World Mycoplasma Testing Questions

Previously Aired on July 13th, 2020

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Overview

Regulatory requirements, lot release, in-process testing, risk mitigation, live mycoplasma requirements, sensitivity, specificity, validation considerations, 28-day vs same day, compendial vs. rapid microbial – What are your mycoplasma questions? Our panel of experts will be live to answer all your questions regarding implementation and validation of a rapid mycoplasma system.

In this live session, you will get answers to your questions.

Potential topics that may arise:

• Key points to consider before validating a qPCR Mycoplasma method

• Different approaches to address regulatory comparability requirements of qPCR to compendial method

• Validation guidance for qPCR mycoplasma method

Who should attend:

• QC/QA Managers

• Process Analytics Managers

• Process Development Managers

• Regulatory Affairs Managers

Presenters

Presenter
John Duguid
(Presenter)
Senior Director, Research & Development,
Vericel Corporation
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Presenter
Mike Brewer
(Presenter)
Director, Global Principal Consultant, Regulatory,
Thermo Fisher Scientific
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Presenter
Michael Sherriff
(Presenter)
Associate Director, Pharma Analytics,
Thermo Fisher Scientific
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Presenter
Suzy Brown
(Presenter)
Field Application Specialist, Pharma Analytics,
Thermo Fisher Scientific
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Presenter
Darren Bauer
(Presenter)
Product Manager,
Thermo Fisher Scientific
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Presenter
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review