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RAPS Florida Chapter: The Medical Device Single Audit Program (MDSAP)
Location:
Medtronic Surgical Technologies
6703 Southpoint Drive North Jacksonville, FL 32216
Date:
January 20, 2017
Time:
8:00 AM - 10:30 PM ET
  • List Price: $25.00
  • Member Price: $15.00
 
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20 January 2017
8:00–10:30 am
Medtronic Surgical Technologies
Jacksonville, FL

The RAPS Florida Chapter is happy to bring this timely interactive presentation to the Northern Florida regulatory community. Come engage with colleauges over breakfast and hear an interactive presentation on the Medical...

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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