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RAPS Philadelphia Chapter Webcast: 21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices
February 15, 2017
12:00 PM - 1:30 PM ET
1.50 RAC
  • List Price: $35.00
  • Member Price: $25.00
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15 February 2017
12:00–1:30 pm EST

The RAPS Philadelphia Chapter invites you to participate in a 90-minute webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.

All medical device manufacturers supplying medical devices to the US are required to maintain a...

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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