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5.00 RAC

Quality System Regulation (QSR)

This course is organized to align with the organization of the subparts and paragraphs as presented in the QSR.


Credits:
5.00 RAC

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

 
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Item Details:

This course is organized to align with the organization of the subparts and paragraphs as presented in the QSR.  It is advisable to have a copy of the QSR in hand to follow along as the course progresses. This course reviews:

  • the background and history of the Quality Systems Regulation...
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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