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4.00 RAC

Project Management for Regulatory Professionals

This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.


Credits:
4.00 RAC

  • List Price: $630.00
  • Member Price: $455.00

 
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Item Details:

Commonly used in engineering and information technology applications, project management principles, tools and techniques also can be used for better planning, control, monitoring and review of project tasks in the regulatory profession. The regulatory profession is well-suited for adopting project...

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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