A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
FDA and MHRA: Annual GCP Inspection Findings
Upcoming Courses
Course Description
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA) are two of the most exacting regulatory authorities in the world. Their specialist inspectors are highly trained to identify problems, deviations and discrepancies in clinical research. One of the best ways to learn about the inspectorate and its areas of focus is to consider the inspection findings which they have made. This web seminar will bring learners up-to-date on the current findings of the MHRA and FDA, which areas cause the regulators the most concern, and how they interpret the regulations and guidance to which they hold researchers accountable.
Learning Objectives
- Describe the remit of the MHRA and FDA
- Explain the main areas of concern to the MHRA and FDA
- Identify the most common and most significant findings being written by the MHRA and FDA
- Describe where the MHRA and FDA apply enforcement discretion
Who Should Attend
- Clinical Researchers from Industry, Academia and CROs
- Quality Assurance Professionals from Industry, Academia and CROs
- Personnel with an interest in the quality of clinical research
Instructor
The course will be led by one of the following instructors:
Elizabeth Ronk Nelson, M.P.H.
Vaska Tone
Click here for complete trainer biographies
Registration Fees
$835
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 3 hours (0.3 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#: 0778-0000-18-028-L01-P. Released: 4/18.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
