Archive: FDA's Bioresearch Monitoring (BIMO) Program

September 18, 2017 | Barnett International Recording

Web Seminar Archives are available in either USB Flash Drive or DVD Format.

Archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

*
*
$735.00

Course Description

This web seminar includes a detailed review of the FDA’s Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at the FDA’s current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.

Video Preview

 

Learning Objectives

  • Review how new regulatory requirements are being incorporated into inspections
  • Discuss the CPGM and rules that support changes in inspection focus
  • Assess the FDA’s application of the inspection manual contents as reflected in regulatory communication
  • Examine steps for preparation of an inspection

Who Should Attend

This course is recommended for experienced:

  • Professionals from Academia whose institutions or investigators hold INDs or IDEs, or whose institutions support clinical research with Site Management Organizations (SMOs)
  • Clinical Quality Assurance Auditors
  • Clinical Quality and Compliance Professionals
  • Clinical Research Associates
  • Project Managers
  • Medical Monitors
  • Regulatory Affairs Professionals
  • Clinical Research Coordinators
  • Sponsor-Investigators
  • Sponsor and CRO Representatives

Instructor

The course will be led by one of the following instructors:

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.