Business Quality and Regulatory Affairs

1.Regulatory IND Process James Ault,RAC, RQAP-GLP VP Quality and Regulatory Affairs Ricerca Biosciences, LLC May 23, 2007 Quality and Regulatory Affairs2. Regulatory IND…

Documents Guidance on 1572

1. Information Sheet Guidancefor Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions -Statement of Investigator (Form FDA 1572) DRAFT GUIDANCEThis guidance…

Health & Medicine FDA Warning Letters - Slide 1

1. You’ve been WARNED…. Everyday occurrences that landed your colleagues with a Warning Letter from the FDA Laura B. Cummins, J.D. Manager, Contract Administration Office…