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2021 - Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
Topics/Call fo Papers
Day 01(10:00 AM - 4:00 PM EDT)
Compare and Contrast FDA, Health Canada, ICH, USP and EP requirements.
The various raw materials and the user impact
Impact of raw materials in the timely production of a product
The impact of the single most used raw material in large molecule production and its impact upon the user
The regulatory requirements for Phase 1 through commercial manufacturing
The use of additional testing – does one only review the C of A
Day 02(10:00 AM - 4:00 PM EDT)
The use of compendial testing in lieu of non-compendial testing – pros and cons
Regulatory risk (ICH Q9) with raw materials
Testing requirements – how to sample
Testing requirements – how to test
The impact of ASQ and square root of N+1 on sample size and attribute testing
Case Studies – Time to apply the previous two days
Warning Letter examples
Compare and Contrast FDA, Health Canada, ICH, USP and EP requirements.
The various raw materials and the user impact
Impact of raw materials in the timely production of a product
The impact of the single most used raw material in large molecule production and its impact upon the user
The regulatory requirements for Phase 1 through commercial manufacturing
The use of additional testing – does one only review the C of A
Day 02(10:00 AM - 4:00 PM EDT)
The use of compendial testing in lieu of non-compendial testing – pros and cons
Regulatory risk (ICH Q9) with raw materials
Testing requirements – how to sample
Testing requirements – how to test
The impact of ASQ and square root of N+1 on sample size and attribute testing
Case Studies – Time to apply the previous two days
Warning Letter examples
Other CFPs
- Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
- Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)
- Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment
- AML/BSA Overview, Compliance, and Current Issues, including new CDD Requirements
- Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
Last modified: 2021-09-26 20:59:30