Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.
Why Should You Attend:
Attendees will learn how to streamline and conduct timely OOS and OOT investigations that meet FDA GMP expectations.
Areas Covered in the Webinar:
Duration: 90 Minutes
Group-Max. 10 Attendees/Location (For Multiple Locations Contact Customer Care) Super Deal - Get CD/USB Drive Free!
LIVE + RECORDED VERSION
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological, and medical device consultancy, which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past years consulting, and previously in industry, Paul’s focus was FDA compliance matters.
Previously, Paul held executive positions with Pfizer, Allergan, and Teva Pharmaceuticals, all related to sterile products. He was also head of the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. He also chaired the industry committee that negotiated the sterile products chapter of the GMP regulations at Health Canada. He has provided expert sworn testimony in various legal cases.