Utah Chapter: Regulatory Affairs Certification (RAC) Device Exam Peer Review Study Group

Thursday, 29 August 2019 (6:30 PM) - Thursday, 26 September 2019 (8:30 PM) Mountain Time (US & Canada)
6350 S 3000 E, Old Mill III Building
Cottonwood Heights, Utah, USA, 84121-5952

RAPS Members: $75
Nonmember: $90

Planning on taking the RAC Device exam? If so, the RAPS Utah Chapter invites you to participate in a series of peer-led study sessions to help you prepare. 

This study group consists of a series of three in-person sessions and is hosted by MasterControl at their Cottonwood Heights facility. Each session will include presentations from certified regulatory professionals who will cover topics addressed in specific chapters outline in the newest release of Fundamentals of Medical Device Regulations, 2nd Edition. To get the most value out of the study group, it is highly recommended that attendees purchase the publication, as it will be the resource that the instructors will be using.

  • 29 August
    1. Chapter 1: History of Food, Drug and Cosmetic Laws
    2. Chapter 2: Overview of Drug, Biologic, Device, Combination Product for Food Regulatory Pathways
  • 12 September
    1. Chapter 3: Clinical Trials: GCPs, Regulations and Compliance for Drugs, Biologics and Medical Devices
    2. Chapter 4: Current Good Manufacturing Practices and Quality System Design
    3. Chapter 5: Medical Device Submissions
  • 26 September
    1. Chapter 6: Medical Device Compliance and Postmarketing Activities
    2. Chapter 7: In Vitro Diagnostics Submissions and Compliance
    3. Chapter 8: Advertising, Promotion and Labeling for Medical Devices and In Vitro Diagnostics (IVDs)

It is highly recommended that registrants possess a minimum of three years regulatory experience, as the session will be geared towards attendees that have a basic understanding of the regulatory profession. Participation in this peer-led study group should not be your only method of exam preparation. RAPS offers many exam preparation materials which can help you develop a comprehensive study plan.

Already an RAC holder? Help out your fellow colleagues by passing on this valuable event information.

A light meal will be available for all participants and the registration fee includes all three sessions. Attendance of each session is the responsibility of the participant and registration is non-transferable.