Decoding FDA's Draft Guidance on Remote Regulatory Assessments: A Practical Guide

Course Description

This web seminar provides a comprehensive overview of the FDA’s recently released draft guidance on Conducting Remote Regulatory Assessments (RRAs). Learners will gain a thorough understanding of RRAs, their implementation, and their impact on FDA-regulated industries. We will explore the key aspects of the guidance, including the types of RRAs, FDA’s expectations, and the potential consequences for regulated entities. By the end of the web seminar, attendees will be equipped with practical knowledge to navigate the evolving landscape of remote regulatory oversight.

Learning Objectives

• Define RRAs and differentiate them from traditional inspections
• Identify the circumstances under which FDA may initiate or request an RRA
• Review the difference between a Mandatory and Voluntary RRA
• Describe the expectations and technological requirements for participating in an RRA
• Explain the potential consequences of declining to participate in mandatory RRAs
• Develop effective strategies for preparing and responding to RRA requests

Who Should Attend

• Quality Assurance Managers
• Regulatory Affairs Professionals
• Compliance Officers
• Clinical Trial Managers
• Clinical Operations Directors
• CRO Project Managers

Instructor

Elizabeth Ronk Nelson, M.P.H.

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.

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 1.5 hours (0.15 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#: 0778-0000-25-021-L99-P. Released: 1/25. 

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