A workshop on converting values to ethics in the industries regulated by the Food and Drug Administration.

Case 1:10-cv-01327-RMC Document 19 Filed 01/07/11 Page 1 of 64 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA UNITED STATES OF AMERICA, Plaintiff, v. REGENERATIVE…

Slide 125 Sept. 2003 Frankfurt, Germany1 U.S. FDA Approach to Auditing Including QSIT Christine Nelson Center for Devices & Radiological Health Food & Drug Administration…

1. Our Leadership for an FDA Inspection:The Managers’ Review Adapted by Mitchell W. Manning Sr. from presentations by former FDA Investigators. 2. Agenda 1. Introduction…

1. “The FDA Inspector Cometh” Inspection Process for Clinical Trials 2. FDA “Good Clinical Practice” Inspections  What has happened at UMHS?  Who conducts the…

1. Team Building for an FDA Inspection: Adapted by Mitchell W. Manning Sr. from presentations by former FDA Investigators The Employee Review 2. 2 Agenda Introduction/Overview…

1. Slide 1 of 13 Rob Packard, President www.MedicalDeviceAcademy.com [email protected] FDA Enforcement Inspections, Trends: A Q&A Session with a former FDA Investigator…

1. FDAMAP Making Regulations Easy…. www.FDAMap.com Email: [email protected] 410-501-5777 20203 Goshen Rd, Suite 261 Gaithersburg, MD 20879 Simple Ways to Prepare For an FDA…

Slide 1Differences in OHRP, FDA and ICH Regulations/Guidelines Monika Haugstetter, MHA, MSN, RN Human Subject Protection Office (HSPO) and Institutional Review Board (IRB),…

Slide 1 FDA Resources and Meetings FDA/EMA Orphan Designation and Grant Workshop Silver Spring, Maryland FDA Campus (White Oak) October 12, 2012 Bill Sutton Deputy Director…