Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

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

Who should Attend

• Regulatory professionals
• Quality professionals
• Manufacturing engineers
• Compliance professionals
• Quality auditors
• Quality engineers
• Microbiology
• Quality Control
• Document control specialists
• In-coming Materials
• Project Managers
• R & D