This web seminar is designed for participants that are sponsors/CROs and research site representatives preparing for a research site FDA inspection. From audit readiness to action item resolution, each site faces its own unique challenges. This course will prepare you and your site for expectations from the FDA and provide concrete steps you can take to prepare before, during and after the inspection.

Learning Objectives

Recognize the anatomy of an audit: The foundation of preparation, the regulations and ICH, types and focus of FDA audits
Review the dynamics of audit readiness: Starting at site selection, preparing sites with large deficiencies
Discuss the mission of the FDA BIMO Program revisions
Recognize the timing of an FDA audit: Audit readiness, action item resolution, follow up after the audit
Identify mechanics of the audit: Start to finish

Who Should Attend

Project Managers
Clinical Research Associates
Site Managers
Research Site Personnel

Instructor

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

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

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

Click here for complete trainer biographies

Registration Fees

$625

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.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.5 hours (0.25 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#: 0778-0000-20-047-L01-P. Released: 1/20.

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