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

Raw material requirements in a cGMP environment are often overlooked as a company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.

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.

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.

Appreciate the requirements for Phase 1 through commercial manufacturing.

Initiation of additional testing -- when?

Who Will Benefit:

Quality professionals

Regulatory professionals

Compliance professionals

Manufacturing engineers

Quality engineers

Quality auditors

Quality Control

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/raw-material-requirements-health-canada-usp-ep-in-a-cgmp-environment-issues-and-solutions-seminar-training-80218SEM-prdsm?channel=sciencedz