Back to On-demand Webcast: Quality Culture and Quality Metrics—Impact and Application: A Practical Approach
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On-demand Webcast: Quality Culture and Quality Metrics—Impact and Application: A Practical Approach

An on-demand recording of the Commissioning Agents’ (CAI) sponsored webcast, Quality Culture and Quality Metrics—Impact and Application: A Practical Approach, originally recorded on 12 July 2017.


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In November 2016 FDA issued a revision of its guidance on its quality metrics initiative. The revised draft has a voluntary phase that will run into 2018, after this time the program will be mandatory. The revised draft narrows the scope by reducing the number of metrics requested....

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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