MycoplasmaMatters – Answers to Your Real-World Mycoplasma Testing Questions

July 13th, 2020 • 8 a.m. PDT, 11 a.m. EDT

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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
View Biography
Presenter
Mike Brewer
(Presenter)
Director, Global Principal Consultant, Regulatory,
Thermo Fisher Scientific
View Biography
Presenter
Michael Sherriff
(Presenter)
Associate Director, Pharma Analytics,
Thermo Fisher Scientific
View Biography
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
View Biography
Presenter
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review