Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
FDA Pre-Approval Inspection Readiness: Sponsors and CROs
Upcoming Courses
Course Description
This course will prepare participants for FDA pre-approval inspections, for pharmaceuticals, biologics, or medical devices. Sponsor/CRO inspections will be addressed. Not only will we review the documents sponsors and CROs need to provide for a GCP inspection, but also the FDA’s rationale for different lines of questioning. Data shows prepared sponsors and CROs are 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 sponsor 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
- Directors and Managers, Clinical Operations
- Quality Assurance Professionals
- Regulatory Affairs Professionals
- Clinical Research Associates
- Project Managers
- Personnel responsible for inspection preparation, representation
Instructor
The course will be led by one of the following instructors:
Jeanne Morris, B.S., MT (ASCP)
Click here for complete trainer biographies
Course Outline
Day One: 8:30 a.m. – 5:00 p.m.
- Regulatory Inspections of Sponsors
- The standards
- Logistics and pre-inspection activities
- Sponsor/CRO inspections
- Post inspection
- Case study
Interactive Activities
- Inspect sample records from the sponsor/CRO 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.
Click here for our seminar cancellation policy
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#: 0778-0000-19-030-L01-P. Released: 4/19.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
