Navigate the FDA and Annex 1: Essential Rules & Regulations for Quality Fill-Finish

This webinar offers a comprehensive exploration of critical topics within parenteral drug product manufacturing, including regulatory guidelines, essential analytical and microbial testing, and phase-specific considerations.

We delve into emerging trends such as Pre-Use Post-Sterilization Integrity Testing (PUPSIT) and Container Closure Integrity Testing (CCIT), as well as highlight common pitfalls to avoid.

Our discussions will also cover key regulatory documents like the CFR and EudraLex, and we'll examine the differences between 21 CFR 211 and Annex 1.

Join our other events to stay ahead with the latest regulatory trends and best practices in the industry!

00:00 – Intro
01:13 – Regulatory Frameworks
03:55 – PUPSIT
06:53 – Regulatory Trends
08:33 – Environmental Monitoring
10:04 – Analytical Testing
13:54 – CCIT
17:43 – Ensuring Quality
19:28 – Conclusion