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3.00 RAC

Regulatory Due Diligence for Product Development

Gain insight into the principles and practices of due diligence within the medical product environment and be better prepared as the due diligence regulatory affairs team member.


Credits:
3.00 RAC

  • List Price: $495.00
  • Member Price: $360.00

 
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Item Details:

This course will provide insight to better prepare the due diligence regulatory affairs team member by providing a basic understanding of the principles and practices of due diligence within the medical product environment. It covers a wide range of issues, including the reasons for performing due...

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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