Dublin, Sept. 02, 2024 (GLOBE NEWSWIRE) -- The "Risk Management of Raw Materials in a GMP Environment Course" training has been added to ResearchAndMarkets.com's offering.
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 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.
6.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.
Who Should Attend:
- 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.
Key Topics Covered:
- 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.
For more information about this training visit https://www.researchandmarkets.com/r/qnx95u
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