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9.00 RAC

GxP Bundle

Examine essential topics within a quality system—Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)—detailing the areas covered by each set of requirements and compares US and international regulations.


Credits:
9.00 RAC

Includes
  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practice (GMP)
  • Good Clinical Practice (GCP)
  • List Price: $1,175.00
  • Member Price: $855.00

 
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Item Details:

This three-course series examines essential topics within a quality system—Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). The GxP Bundle details the areas covered by each set of requirements and compares US and international regulations.

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» View the Table of Contents

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