Back to On-demand Webcast: Creating Compliant Content While Accelerating Time-to-Market
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On-demand Webcast: Creating Compliant Content While Accelerating Time-to-Market

An on-demand recording of the RAPS Webcast, Creating Compliant Content While Accelerating Time-to-Market, originally recorded on 9 November 2016.


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The explosion of digital media and dynamic content drives the need for organizations to create and distribute commercial content with speed and accuracy. Learn best practices on how to increase content time-to-market while maintaining compliance from Brian Harper, director of...

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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