Meeting Details

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RAPS Florida Chapter: Keys to Planning and Handling a Medical Device Recall
888 Executive Center Drive West St Petersburg, FL 33702
March 16, 2017
8:00 AM - 10:30 PM ET
2.00 RAC
  • List Price: $30.00
  • Member Price: $20.00
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The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Product liability and financial risks are staggering when companies fail to properly report and take action when required. Firms need to voluntarily remove their...

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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