Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
|Articles|October 24, 2011
Compliance Insight Podcasts: Implementing Process Validation - Episode 3
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Step-by-Step Validation for Bio/Pharmaceuticals: Meeting New Regulatory Expectations
Optimizing cleaning validation - Episode 3
Listeners will walk away with knowledge of how to prevent cross-contamination in bio/pharmaceutical manufacturing using a risk-based approach, including how to handle unique challenges that occur with continuous processing and revalidation. Best practices and regulatory expectations from ICH Q9 guideline, the ISPE Risk MaPP guideline, and the ASTM 2500 Standard Guide for Specification, Design, and Verification for Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment will be addressed.
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