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RAC (US) Preparation Virtual Program (Spring 2018)
February 5, 2018 To March 31, 2018

Put your best effort forward for the RAC (US) exam with the RAPS RAC (US) Preparation Virtual Program. Experts provide comprehensive coverage of the topics on the RAC exam, including applied examples, case studies and Q&A sessions.

  • List Price: $1,100.00
  • Member Price: $1,000.00
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5 February – 31 March 2018

The RAC (US) Prep Virtual Program provides a thorough knowledge of regulatory functions throughout product lifecycle for medical devices, IVDs, pharmaceuticals and biologics. Using the Fundamentals of US Regulatory Affairs book as a foundation, the program provides...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design