'Fda warning letter' presentation slideshows

Investigator Responsibilities for Research

Investigator Responsibilities for Research. Jan Zolkower, MSHL, CIP, CCRP January 13, 2012. Agenda. Review Investigator Responsibilities Discuss recent FDA Warning letters and OHRP Determination letters Review of Advanced Notice of Proposed Rulemaking (ANPRM) Q & A. PI Responsibilities.

708 views • 57 slides

Investigator Responsibilities for Research

Investigator Responsibilities for Research. Shannon Simmons, BA, CIP March 14, 2014 Process Improvement Team Vanderbilt Human Research Protections Program. Agenda. Review Investigator Responsibilities Discuss FDA Warning letters Q & A. PI Responsibilities.

510 views • 50 slides

Lessons Learned from FDA Warning Letters

Lessons Learned from FDA Warning Letters. Partners Human Research Quality Improvement Program QUICK BITE Series September 2, 2004. Lessons Learned from FDA Warning Letters. What is a warning letter? Why should you care if you are not conducting FDA-regulated research?

409 views • 25 slides

Joan A. Kavuru, J.D. Director of Compliance July 20, 2006

264 views • 16 slides

How to tackle warning letters in Pharma Manufacturing?

Warning letters are issued by the FDA to people or associations for infringement of regulatory importance. https://qmssystems.com/

26 views • 2 slides