Meeting Details

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Atlanta Chapter: Introduction to Cybersecurity Risk for Medical Devices
Location:
AGFA Health Care Corporation
10 S Academy St Greenville, SC 29601-2632
Date:
June 9, 2017
Time:
9:00 AM - 12:00 PM ET
Credits:
3.00 RAC
  • List Price: $45.00
  • Member Price: $30.00
 
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Risk management professionals are seeing an increase in regulatory demands to manage cyber risk for medical devices. This seminar introduces attendees to cybersecurity in general using everyday examples, then applies that frame of reference to medical device risk. Attendees will learn how to apply...

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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