Microbial Identification and Control - Meeting Regulatory Requirements

Previously Aired on August 23rd, 2023

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Overview




Microbial control within biopharmaceutical manufacturing is a critical quality control to help ensure drug products are free from viable microorganisms. Per regulatory guidelines, the implementation of an environmental monitoring program is required to comply with current good manufacturing practices (cGMP) and identification of microorganisms to species level is a minimal requirement.

Join us for a discussion on implementing an environmental program, including regulatory expectations, as well as a brief introduction to the Applied Biosystems™ MicroSEQ™ Rapid Microbial Identification System.

In this webinar you’ll learn:

  • Rationale and regulatory expectations for microbial control strategy during bioproduction workflows
  • Comparison of methods used for microbial identification
  • MicroSEQ™ ID system workflow for bacterial and fungal identification
Who should attend:
  • Process development
  • Cell line development
  • Biosafety
  • Scientists: QC, Staff, Analytical

Presenters

Presenter
Nico Chow
Field Application Specialist, Pharma Analytics
Thermo Fisher Scientific
View Biography
Presenter
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review