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Training Overview
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 training seminar 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.
Please plan to bring additional personnel to the webinar to obtain cross-Department training.
Training Agenda
- 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.
- ASQ Testing square root of “n” plus 1 vs the ASQ methodology.
Who Will Benefit from this Course?
The following Departments may benefit from this training:
- QC and analytical methods scientists and managers
- QA directors, managers and personnel
- Compliance/Regulatory affairs professionals
- Managers of GMP facilities
- Supply chain managers
- Purchasing and Materials Control managers
- GMP site personnel
- Senior managers of companies using CMOs
- People investing in FDA-regulated product development projects.
Faculty Barry A. Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Dr. Barry A. Friedman holds 30+ years of experience in aseptic processing, and regulatory compliance. Testing raw materials, environmental controls, microbiological factors, QC compliance, and analytical chemistry are his core expertise. Additionally, he has also worked on phases 1, 2, and 3, and commercially certified products obtained from bacteria, yeast, and mammalian cells. Since Dr. Friedman specializes in aseptic processing, internal audit, and regulatory compliance, you can discuss validation criteria and techniques to pass the FDA inspection.
