Traditional microbiological test methods may not meet the turnaround time required to release the critical therapies needed by patients based on the rise in novel and compounded therapies.

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 2024!

Our 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.
Hear in-depth presentations featuring solutions to challenges during method selection, considerations for cell and gene therapies and short shelf-life products, and best practices for validation.

Be inspired by case studies highlighting real-life implementation success stories.
Don’t miss out on small group work sessions providing additional takeaways related to cost, overcoming challenges, and the benefits of nontraditional microbiology test methods!

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