Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions is a seminar that addresses the raw material requirements in a cGMP environment.
Topics
FDA, Health Canada, ICH, USP and EP requirements
Latest updates to include FDA, Health Canada, ICH, USP and EP requirements
A variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2, 3 and commercial production
Testing requirements during each Phase (Phase appropriate), to include microbial and endotoxin, and what may be optional (regulatory risk ) until the product moves to its next Phase
What options exist - even within a Phase 2 or Phase 3 testing framework
Compendial vs. non-compendial testing and how to respond when no method is available
How a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing
The number of lots required for testing before reduced testing might occur and why some companies don`t accept this route
The use of individual samples vs. composite samples for testing
Packaging and storage requirements and their impact on in-coming materials to include both raw materials and API
ASQ testing to include how to choose attributes and sample size
When the ASQ vs. square root of N+1 is appropriate
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions - 2025, Webinar (48594)
Past Events
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions - 16-17 Mar 2023, Philadelphia, Pennsylvania, United States (60560)
Important
Please, check "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions" official website for possible changes, before making any traveling arrangements
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