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.
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions covers topics such as:
- 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 brings together:
- 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
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions might be held in United States in 2025.