2020 - Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

Upon completing this course on raw material requirements in a cGMP environment participants will:
Understand how various types of raw materials may impact the user.
Learn of the impact of raw materials to include any bacterial and endotoxin issues in the timely production of a product.
Determine the single most used raw material in large molecule production and what it means to the user.
Find the sources of analyses assistance for raw materials.
Appreciate the requirements for Phase 1 through commercial manufacturing—why safety is required as part of Phase 1
Initiation of additional testing -- when?
Examination of regulatory risk to include ICH Q7, Q9 and Q11.
Why use compendial testing in lieu non-compendial testing.
Testing requirements -- when is enough?
Understand packaging and storage requirements and their impact on in-coming materials to include both raw materials and API.
The impact of ASQ vs. square root of N+1 on sample size and attribute testing.