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4.00 RAC

Good Manufacturing Practice (GMP)

This course provides a basic understanding of current Good Manufacturing Practices (CGMP) and their impact on product quality and patient safety. It covers a wide range of issues including US and EU regulations.


Credits:
4.00 RAC

  • List Price: $630.00
  • Member Price: $455.00

 
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Good Manufacturing Practice (GMP) is a term that is recognized worldwide for the control and management of manufacturing and quality control of active pharmaceutical ingredients, foods, pharmaceutical products and medical devices. GMP regulations and guidance are designed to ensure that products...

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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