Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions, San Diego, Thursday, 03. October 2019

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.
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.
Explore ASQ testing to include how to choose attributes and sample size.

The objective of this two day seminar is to explore raw materials and their requirements – issues and solutions. It will also explore how water impacts the final product since water is the single largest raw material that is used within most processes. Another objective is to assure that your organization is maintaining itself within a cGMP compliance framework. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.
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?
Examination of regulatory risk (ICH Q9).
Why use compendial testing in lieu non-compendial testing.
Testing requirements -- when is enough?
The impact of ASQ on sample size and attribute testing.

Who Will Benefit:

Quality professionals
Regulatory professionals
Compliance professionals
Manufacturing engineers
Quality engineers
Quality auditors
Quality Control
Document control specialists
R & D


Barry A. Friedman, in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.
Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

For Registration -   
Note: Use coupon code REFERRAL10 > and get 10% off on registration.

Thursday, 03. October 2019, San Diego, Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

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