QRM Call for Volunteers

PDA is seeking volunteers to serve as team members for the PDA TR 54 series. This Task Force is expected to begin work in September 2025 and will be responsible for reviewing, revising, and supporting the content of one or more of the following Technical Reports:

• TR 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
• TR 54-2, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, Annex 1: Case Study Examples for Quality Risk Management for Packaging and Labeling Operations
• TR 54-3, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products
• TR 54-4, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances
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• TR 54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems
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• TR 54-6, Formalized Risk Assessment for Excipients

This Task Force will operate under the guidance of a QRM Steering Committee and may be split into multiple workstreams.

This is a virtual position.

This opportunity is open to Members only.

Thank you for your interest! A member of the QRM Steering Committee will reach out to you soon.

If you are interested in joining this team, please submit your application by completing the survey.