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3.00 RAC

Supply Chain Controls

Examine common supply chain issues, key steps in supply chain control and ways FDA encourages organizations to improve their supply chain controls through guidance documents and regulatory harmonization activities.


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A supply chain is a series of linked activities and organizations to transform natural resources, raw materials, components, services and information into a finished product that is then delivered to the end customer. Supply chain controls are designed to minimize risk to a finished product, from...

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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