Jul 14 - 15

Boston, MA

This highly interactive two day seminar on raw material requirements in a cGMP environment will: Consider Health Canada, FDA, USP and EP requirements. Examine 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. Cover testing requirements during each phase and what may be optional (regulatory risk) until the product moves to its next phase. Determine what options exist - even within a Phase 2 or Phase 3 testing framework. Discuss compendial vs. non-compendial testing and how to respond when no method is available. Discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing. Explore the number of lots required for testing before reduced testing might occur and why some companies don't accept this route. Review the use of individual samples vs. composite samples for testing. Learning Objectives: 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 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. Who Will Benefit: Quality professionals Regulatory professionals Compliance professionals Manufacturing engineers Quality engineers Quality auditors