Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators

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Course Description

The primary reason the FDA performs inspections is to support its mission to protect the public by ensuring the safety and efficacy of drugs, biologics, and medical devices. In 2006, the FDA announced an initiative to modernize the regulation of clinical trials, including the Compliance Program Guidance Manual (CPGM) Bioresearch Monitoring Program (BIMO). The purpose of the FDA compliance program is to provide instructions to the FDA field investigator and the FDA center personnel in the conduct of FDA inspections. This web seminar will review both the FDA CPGM BIMO for sponsors, CROs, and monitors and the FDA CPGM BIMO for Clinical Investigators and Sponsor-Investigators.

Learning Objectives

  • Describe how the FDA CPGM BIMO is used in FDA inspections
  • Define the types of FDA inspections
  • Identify the most common type of Inspection findings for sponsors, CROs, and Investigators
  • Examine how the FDA CPGM BIMO can aid in preparation for an inspection prior, during, and at the completion of a clinical trial

Who Should Attend

  • Clinical Investigators
  • Clinical Research Coordinators
  • Clinical Quality Assurance and Compliance Auditors
  • Clinical Research Associates
  • Medical Monitors
  • Project Managers
  • Regulatory Affairs Professionals

Instructor

Marla Hoelle, R.N, B.S.N., C.C.R.A, P.M.P.

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Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-20-057-L01-P. Released: 3/20. 

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