A Straightforward Path Toward Regulatory Compliance and Data Integrity with Your Microbial Testing Systems

August 26th, 2021 • 8 a.m. PT, 11 a.m. ET

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Overview

Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from assays to data integrity, be qualified and validated to meet regulatory guidance in a CGMP environment. Therefore, when choosing a microbial testing solution, it’s important to have a clear path toward regulatory compliance from the start in order to avoid any costly complications down the road.

In this webinar we will share experiences with a variety of strategies toward implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.

In this webinar you’ll learn:

  • An overview of the regulatory guidance around validation of a microbial testing and identification system in the CGMP environment
  • Details of a microbial identification system designed to meet regulatory requirements
  • Complete computer systems validation plan, including data integrity, IQ/OQ/PQ, and 21 CFR part 11 compliance
Who should attend:
  • QC Microbiologists
  • QC Lab Managers
  •  QA Professionals
  • Validation Specialists

Presenters

Presenter
Darryl León, PhD
(Presenter) Senior Product Manager,
Pharma Analytics, BioProduction Group
Thermo Fisher Scientific
View Biography
Presenter
Sandi True, PhD
(Presenter) Staff Scientist, Pharma Analytics Field Applications Team,
BioProduction Group
Thermo Fisher Scientific
View Biography
Presenter
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review