Back to Pharmaceuticals: Compliance & Audits
5.00 RAC

Pharmaceuticals: Compliance & Audits

This course will provide fundamental good quality auditing practices knowledge and skills for pharmaceuticals. It is intended to review the background on auditing practice and the evolution of the requirements from a regulatory point-of-view, and present an overview of the applicable regulations.


Credits:
5.00 RAC

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

 
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Many agencies around the world are tasked with regulating the healthcare product industry within their respective countries, including: the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), Japanese Ministry of Health, Labour and Welfare (MHLW), Australia’s...

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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