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On-demand Webcast: Writing Effective Test Reports and Persuasive Test Summaries

An on-demand recording of the Med Institute Sponsored Webcast, Writing Effective Test Reports and Persuasive Test Summaries, originally recorded on 26 April 2017.


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1.50 RAC

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Wednesday, 26 April 2017
12:00-1:30pm ET

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Successful submissions include clear and compelling data demonstrating the safety and effectiveness of your product. Writing test reports that meet current regulatory and quality expectations is critical. But test reports can include a great...

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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