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RAPS DC/Baltimore Chapter: Data Integrity Basics for Regulatory Affairs Professionals
RAPS Headquarters
5635 Fishers Lane, Suite 550 Rockville, MD 20852
March 27, 2017
5:30 PM - 8:00 PM ET
2.00 RAC
  • List Price: $45.00
  • Member Price: $30.00
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During FDA drug and device inspections, investigators now ask to see the firm’s system that ensures the accuracy and consistency of its data. When firms fail to have a system, or the system is inadequate, FDA officials issue 483 observations send warning letters.

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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