Back to On-demand Webcast: RAC (US) Exam Preparation (2016)-Biologics
2.00 RAC

On-demand Webcast: RAC (US) Exam Preparation (2016)-Biologics

An on-demand recording of the RAC (US) Exam Preparation Webcast – Biologics originally recorded in August 2016.

2.00 RAC

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Passing the RAC exam takes hard work and a lot of preparation. As part of a complete study plan for the RAC (US) exam, this popular webcast series can help, particularly with the exam’s analysis and application to the workplace components. This RAPS webcast series will provide applications and...

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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