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2021 - Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

Date2021-11-04 - 2021-11-05


VenueVirtual Seminar, USA - United States USA - United States



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

Last modified: 2021-09-26 20:59:30