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5.00 RAC

Medical Devices: Compliance & Audits

This course will provide an understanding of what is required to conduct a medical device quality system audit and teach basic techniques for conducting audits.

5.00 RAC

  • List Price: $735.00
  • Member Price: $535.00

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Auditing is a reality in the world of medical devices. There are many types of audits, including, but not limited to, first-party, internal, independent, supplier, external and agency audits. Regardless of the audit’s nature and scope, the outcome is basically the same. Typical audit outcomes...

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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