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6.00 RAC

Supplier Management

This course provides a basic understanding of current supplier management practices and their impact on product quality and patient safety.

6.00 RAC

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

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Supplier management—also known as “vendor management”—is a term encompassing a broad array of regulatory requirements and industry activities necessary to develop, manage and control active pharmaceutical ingredients, foods, pharmaceutical and biological products, cosmetics, veterinary products and...

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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