Back to On-demand Webcast: QMS Support to Post-Market Surveillance Under China Order 650
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On-demand Webcast: QMS Support to Post-Market Surveillance Under China Order 650

An on-demand recording of the RAPS Webcast, QMS Support to Post-Market Surveillance Under China Order 650, originally recorded in August 2015.

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The newly revised Regulations for Supervision and Administration of Medical Devices established the chapter on Adverse Event Handling and Medical Devices Recall, with the purpose to enhance the control over regulate supervisory activities throughout the whole product life cycles.

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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