Publicly accessible Webinar on FDA Study Results

GMP News No. 851

GMP News
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:

  • Probability of a production facility being chosen for a FDA inspection
  • The effect of education, experience and individual effects on the inspection findings
  • Characteristics of a production facility correlating with the probability of GMP deviations

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:
http://www.olin.wustl.edu/faculty/nickerson/results/FDATest1_files/Default.htm

Prepared by:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)
  

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