FDA Pre-Approval Inspection Readiness: Clinical Investigators

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Course Description

This course will prepare participants for FDA pre-approval inspections, for pharmaceuticals, biologics, or medical devices. Clinical Investigator inspections will be addressed. Not only will we review the documents Investigators need to provide for a GCP inspection, but also the FDA’s rationale for different lines of questioning.  Data shows a prepared Investigator is more likely to have a successful inspection.

The course will focus on a detailed review of the FDA Compliance Programs. For each topic in the Compliance Program, the questions the Investigator should expect, different ways questioning will be completed, and the types of documentation to be provided to readily satisfy FDA requests will be outlined. The information covered can be used to prepare Inspection Management teams and Subject Matter Experts.

Learning Objectives

  • Understand what to prepare/FDA inspection logistics
  • Identify what you can do on site to prepare for an FDA inspection
  • Learn what to expect and provide during an FDA inspection
  • Apply learning to real-life situations by inspecting records using FDA techniques

Who Should Attend

  • Clinical Research Coordinators
  • Principal Investigators
  • Project Managers
  • Personnel responsible for inspection preparation, representation


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

Jeanne Morris, B.S., MT (ASCP)

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Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • Regulatory Inspections of Clinical Investigators
  • The standards
  • Logistics and pre-inspection activities
  • Clinical Investigator inspections
  • Post inspection
  • Case study


Interactive Activities

  • Inspect sample records from the Clinical Investigator site using the same techniques as the FDA

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

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Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 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#: 0778-0000-19-023-L01-P. Released: 4/19.


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