Dublin, July 25, 2023 (GLOBE NEWSWIRE) -- The "Risk Management of Raw Materials in a GMP Environment Course" training has been added to ResearchAndMarkets.com's offering.
This live, interactive presentation aims to shed light on an often overlooked aspect of product development - the management of raw materials in a cGMP (Current Good Manufacturing Practice) environment.
Depending on the product being developed, such as tablets and capsules or biotechnology products, a significant number of raw materials, ranging from fifteen to twenty or even up to sixty, may need to be sourced and accepted before the production process can proceed from initiation to completion.
During this training, participants will receive extensive insights into the issues surrounding raw materials, particularly focusing on microbial and endotoxin contamination - a concern that regulatory bodies like the FDA, EMA, and Health Canada have recently emphasized.
The course will cover various topics, including testing requirements for raw materials during different phases of clinical trials (Phase 1 through Phase 3). It will discuss the differences between compendial and non-compendial testing, challenges related to small vs. large molecules, and how packaging and storage requirements can impact incoming materials like raw materials and API (Active Pharmaceutical Ingredients).
The training will explore strategies for testing raw materials and reducing testing as the number of lots tested increases. It will also compare alternative sampling methodologies, such as the square root of "n" plus 1 and the American Society for Quality (ASQ) methodology.
Notably, attendees can earn 6.0 RAC credits from RAPS (Regulatory Affairs Professionals Society) upon completing the course.
Who Should Attend:
This training is beneficial for professionals from various departments, including:
- 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 Contract Manufacturing Organizations (CMOs)
- Investors in FDA-regulated product development projects.
Key Topics Covered:
- Developing an overall testing strategy for raw materials in a Phase 1 through Phase 3 environment.
- Understanding required raw material testing during each phase of clinical trials.
- Interpreting Certificate of Analysis (COA) and its limitations.
- Managing non-compendial testing.
- Addressing issues with small vs. large molecules.
- Identifying types of raw materials and their concerns to users.
- Considering packaging and storage requirements' impact on incoming materials.
- Analyzing the impact of raw material receipt on timely production.
- Reviewing validation criteria and recommendations for microbiological validation.
- Identifying the most commonly used raw material in large molecule production.
- Utilizing sources of analyses assistance for raw materials.
- Initiating additional testing and determining the appropriate timing.
- Learning from Warning Letters related to Raw Material issues.
- Comparing ASQ Testing square root of "n" plus 1 with the ASQ methodology.
Speaker:
The training will be led by Barry A. Friedman, Ph.D., a highly experienced consultant with over 30 years of industrial managerial experience in biopharmaceuticals and medical devices. Dr. Friedman's expertise spans regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations, and fermentation technology.
He previously held key positions at Cambrex Bio Sciences and Chesapeake Biological Laboratories, managing various aspects of biopharmaceutical production. Dr. Friedman holds a Ph.D. in Microbiology and brings extensive client and regulatory interaction experience to the training.
In conclusion, this training is a valuable opportunity for professionals in the pharmaceutical industry to gain essential knowledge and expertise in managing raw materials effectively in a cGMP environment. By attending this course, participants can equip themselves with the necessary skills to enhance product development and compliance with regulatory standards.
For more information about this training visit https://www.researchandmarkets.com/r/m3vr8k
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
