Meeting Details

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    • Event Details
RAPS Atlanta Chapter: Annual Breakfast With the Atlanta FDA District Office
Location:
Arnall Golden Gregory, LLP
171 17th St NW Ste 2100 Atlanta, GA 30363-1031
Date:
December 8, 2017
Time:
7:30 AM - 10:30 AM ET
Credits:
2.00 RAC
  • List Price: $45.00
  • Member Price: $30.00
 
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It’s that time of year again! The time when representatives from the Atlanta District Food and Drug Administration (FDA) engage directly with regulatory professionals from the Atlanta metropolitan area. FDA representatives will present on the latest compliance and enforcement related topics, and...

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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