Back to Medical Devices: Corrections, Removals and Directed Recalls
6.00 RAC

Medical Devices: Corrections, Removals and Directed Recalls

This course examines compliance with US FDA, Health Canada, and European Union requirements and regulations. The definitions of the recall classification and type are explained together with the importance of the recall strategy, planning, communication, reporting and record keeping.


Credits:
6.00 RAC

  • List Price: $770.00
  • Member Price: $550.00

 
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Medical device recalls are a difficult aspect for medical device manufacturers and distributors, and most importantly, with the end users of these devices. Balancing the needs of the users along with the various regulatory requirements creates challenges for those responsible for deciding and...

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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