cGMP Regulatory 2020 - What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections Live Webinar

Join us for a webinar on September 15 for a discussion of the webinar
GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national laws.
It has often been stated that “FDA inspects for compliance; European inspectors inspect for adequate science”. Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.
U.S., EU and Japan GMPs - Status of Harmonization& Future Trends
Current status of harmonization of GMP requirements
Future Trends
Where Inconsistencies Become a Problem: WHO, ICH, Countries
Discrepancies in global expectations
Alignment issues
Key Chapter Reviews
ICH GMP organization
Category reviews
Speaker:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.