Dublin, July 25, 2023 (GLOBE NEWSWIRE) -- The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course" training has been added to ResearchAndMarkets.com's offering.
This two-day highly interactive course focuses on the raw material requirements in a cGMP (current Good Manufacturing Practice) environment for developing new products. It covers various regulatory requirements from FDA, Health Canada, ICH, USP, and EP and provides updates on these requirements. The training aims to help participants understand the impact of different raw materials, testing requirements during each phase of production, compendial vs. non-compendial testing, packaging and storage requirements, and the use of ASQ (Acceptable Quality Level) testing.
The learning objectives of the course are as follows:
- Understand how various types of raw materials may impact the user.
- Learn about the impact of raw materials on timely production and potential bacterial and endotoxin issues.
- Recognize the importance of the single most used raw material in large molecule production.
- Identify sources of analysis assistance for raw materials.
- Appreciate the requirements for Phase 1 through commercial manufacturing and why safety is required in Phase 1.
- Understand the initiation of additional testing and regulatory risks (e.g., ICH Q7, Q9, and Q11).
- Learn about compendial testing vs. non-compendial testing and when to use each.
- Explore testing requirements and sampling methods.
- Understand the impact of ASQ vs. square root of N+1 on sample size and attribute testing.
The target audience for this training includes quality professionals, regulatory professionals, compliance professionals, manufacturing engineers, quality engineers, auditors, microbiology experts, R&D personnel, project managers, and others involved in the pharmaceutical and biotechnology industries.
The speaker for the seminar is Barry A. Friedman, Ph.D., an experienced professional with over 30 years of industrial managerial experience in biopharmaceuticals and medical devices. He has expertise in regulatory compliance, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations, and fermentation technology.
The training covers various topics over two days and includes case studies and examples of warning letters to illustrate regulatory issues related to raw materials.
For more information about this training visit https://www.researchandmarkets.com/r/yumue4
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.
