PDA Pacific Northwest: Objectionable Organisms- A Risk Based Approach

Seattle, WA
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The PDA Pacific Northwest Chapter proudly present a hybrid event on Evaluating the Impact of Different Microorganisms in Non-Sterile Manufacturing.

The hazard posed by microorganisms identified through process monitoring or finished product testing will depend upon the nature of the manufacturing process, product characteristics, and traits of the microorganism. Each microorganism isolated from a non-sterile manufacturing process or product should be evaluated using a risk-based approach to determine whether it should be categorized as objectionable. This presentation will provide an overview of the regulations, standards, and guidance documents defining objectionable organisms in various product types and introduce a risk assessment tool for evaluating the hazards posed by microorganisms.

Guest Speaker

Tiffany Baker

Tiffany Baker is a Senior Consultant at ValSource, LLC, specializing in development and implementation of innovative approaches to quality risk management (QRM). Tiff is an active member of PDA, a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on QRM. She is co-lead for the PDA Task force on remote audits and inspections. Additionally, she was an author for the revision to ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process.

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