21/22 October 2020
GMP News No. 851
7 December 2006
Publicly accessible Webinar on FDA Study Results
In our GMP news from 30 November 2006 we reported about the comprehensive study the FDA had commissioned in 2002. This study analyses confidential FDA internal data on GMP inspections and deviations from 42 pharmaceutical, API and biotech companies.
The study's most important results are introduced in a 45 minute presentation by the two authors and FDA Co-Principal Investigators Jeffrey T. Macher and Jackson A. Nickerson. The presentation's core is a static model intended to make the following predictions:
The presentation is a must for everybody working in the area of GMP compliance, and especially for those in FDA regulated compliance.
To start the presentation, go to the following link. As for ECA
webinars, you will need a PC with speakers: