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Stability Studies and Validation (FDA Compounding Conference 2025)



About:

Explore recent examples of inspection deficiencies found at outsourcing facilities and testing laboratories under 21 CFR Part 211.166. Learn the do’s and don’ts when using a stability program, either in-house or at a contract laboratory.

Presenter:

Sherry (Xiaohui) Shen
Consumer Safety Officer
FDA

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