Regulatory Affairs and Quality Assurance - US Current Good Manufacturing Practices (cGMP) and CMC for pharmaceutical products. Peivand Pirouzi, Ph.D.

Current Good Manufacturing Practices (cGMP), and CMC Development: 21 CFR Part 211, ICH-Q7, and FDA Warning letters.
Dive into the essentials of Current Good Manufacturing Practices (cGMP) and CMC (Chemistry, Manufacturing, and Controls) development in this detailed video guide. Explore critical regulatory frameworks such as 21 CFR Part 211, ICH-Q7, and their role in ensuring the safety and quality of pharmaceutical products. Key topics covered include:
Understanding cGMP principles and their application in manufacturing and quality assurance.
A step-by-step breakdown of CMC development and its significance in the drug approval process.
Insights into FDA warning letters: common compliance issues and how to avoid them.
Best practices for maintaining compliance with ICH-Q7 and 21 CFR Part 211.
This video is an invaluable resource for regulatory professionals, quality assurance teams, and anyone working in pharmaceutical manufacturing and development. Stay informed and ensure compliance with industry-leading standards.