Comprehensive Monitoring for Medical Devices
February 17-19, 2016
Philadelphia, PA
Monitoring Clinical Drug Studies: Intermediate
February 17-18, 2016
Philadelphia, PA
Quality System Management Approach in a GCP Environment
February 23-24, 2016
San Diego, CA
Clinical Project Management: Intermediate
April 5-6, 2016
San Diego, CA

FDA Proposed Rule 2010: Sponsor Requirements to Report Fraud December 2010

Dec 3, 2010
Order the DVD of this seminar

Course Description 

This course will present the content and discuss the impact of the new FDA draft regulatory amendment to 21CFR312.56 & 21CFR812.46 regarding the sponsor responsibility for review of ongoing investigations and monitoring investigations, respectively. The seminar will present events leading up to the draft, and include a discussion of what reporting a suspicion of fraud vs. a confirmed case of fraud means, as well as discussion of what is not in the rule that was anticipated.



Learning Objectives 

  • Recognize the history of the draft regulation and events leading to the release
  • Review the content of the draft related to 21CFR312 & 21CFR812
  • Examine implications on stakeholder activities

Who Should Attend 

  • Sponsors/CROs
  • Project Management
  • Medical Writing
  • Regulatory
  • QA
  • Data Management


Sandra ”SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.

Click here for complete trainer biographies 

Course Length Time 

1.5 hours 2:30 – 4:00 p.m. Eastern

Course Dates 

December 3, 2010