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27th August 2024  Content supplied by: Parenteral Drug Association (PDA)

Learn How to Navigate Alternative Microbiological Method Implementation


The EU GMP Annex 1 revision and the recently proposed USP Pharmacopeial Forum draft chapters stress the importance of incorporating alternative microbiological methods in process/facility monitoring and release test methods.

Learn how to successfully navigate the evaluation and adoption of rapid and alternative microbiological methods at the hands-on PDA Alternative Microbiological Methods Workshop, 09-10 October in Washington, DC!

The experts will guide you through selecting a test method, implementing the testing platform, and preparing appropriate data packages and methods validation summaries for regulatory submission.

Don’t miss out on case studies and multiple small group work sessions providing additional takeaways related to cost, overcoming challenges, and the benefits of nontraditional microbiology test methods.

Hear from the experts during sessions covering key topics:

  • Evolution of Alternative Microbiological Methods and Regulatory Insights
  • Real-Life Challenges to Implementing AMM
  • Regulatory Expectations on Alternative Microbiological Methods
  • Releasing the Power of Alternative Microbiological Methods
  • From Cultures to Code: Alternative Microbiology at the Molecular Level
  • Future Directions for Alternative Microbiological Methods

 

This workshop following the PDA Pharmaceutical Microbiology Conference sells out quickly!

Find out more


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Date Published: 27th August 2024

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PDA Announce New EU GMP