Risk Management of Raw Materials in a GMP Environment

Why Should You Attend:

Risk management of raw materials in a cGMP environment is an area that is 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 raw materials or as many as sixty need to be sourced and accepted before the process can be moved from initiation through completion. This live, interactive presentation will extensively review this area. It will also delve into the renewed issue of microbial and endotoxin contamination of these raw materials and why the FDA, EMA and Health Canada have recently focused on them.

This live, interactive training webinar will also examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2 and 3. It will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase. It will determine what options exist -- even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. The presentation will also discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay your initiation of testing. Further, it will consider packaging and storage requirements and their impact on in-coming materials to include both raw materials and API.

The live, interactive training webinar will explore the number of lots required to be tested before reduced testing might occur and why some Companies don't accept this path. It will also review the use of individual samples vs. composite samples for testing. It will also consider the option of using the square root of “n” plus 1 vs the American Society for Quality (ASQ) methodology as alternative sampling methodologies.

Areas Covered in the Webinar:

• How to develop an overall strategy for testing raw materials in a Phase 1 through Phase 3 environment.
• What raw material testing is required during each Phase of clinical trials.
• What your Certificate of Analysis (COA) may and may not tell you.
• How to manage non-compendial testing.
• Issues with small vs. large molecules.
• Types of raw materials and their concerns to the user.
• Packaging and storage requirements and their impact on in-coming materials
• Impact of raw materials receipt in the timely production of a product.
• Review of validation criteria and recommendations for satisfying each as part of a microbiological validation.
• What is the single largest used raw material in large molecule production.
• Sources of analyses assistance for raw materials.
• Initiation of additional testing -- when???
• Observe Warning Letters related to Raw Material issues.

Who Will Benefit:

• In-coming Materials
• Quality Control
• Quality Assurance
• Regulatory Compliance
• Manufacturing
• Validation
• Research & Development
• Project Management

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

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology.

From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, 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 compliance interactions.

In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi, TungstenShield (PharmaWebinars), IPA (Canada), Executive Conference Corp, Compliance On-Line and Pharmig (UK).

Dr. Friedman maintains an active Blog (www.barryafriedmanphdllc.com) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues as well as over 1,500 “Search” terms to assist with finding the appropriate Warning Letter and FDA 483. He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.

Follow us :