Meeting Details

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RAPS Florida Chapter: The World of Quality Metrics—Yesterday, Today and Tomorrow
April 27, 2017
12:00 PM - 1:00 PM ET
1.00 RAC
  • List Price: $30.00
  • Member Price: $20.00
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The RAPS Florida Chapter invites you to participate in a 60-minute webcast covering the importance of quality metrics in regulatory, with particular focus on the differences between CDER and CDRH initiatives.

In 2011, CDRH launched “The Case for Quality” initiative in an effort to advance the focus...

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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