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Ethics--Essential Tools for Regulatory Professionals

Better understand your customers' expectations and learn how to handle complex ethical challenges with valuable insight on building consumer trust and continuity. This course provides a general introduction to complex concepts, principles and theories, including bioethics and legal principles.

4.00 RAC

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Making the right decision isn’t always easy. Consumers today expect and demand integrity, honesty and transparency. Learn the importance of doing the right thing when product quality is at risk, from history to actual cases that effected consumer safety and trust, so you’re better prepared to deal...

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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