R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks throughout the Drug Development Lifecycle

Overview

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The short course will provide an overview of the development of a cross functional quality strategy framework in an R&D QA organization which, when implemented will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle. Business and operations risks are not addressed in this course. Examples will be workshopped to demonstrate how this methodology can help assure confidence in the quality oversight in preparation for submission to regulatory agencies and for inspections. The value of this approach will be shown, revealing the positive impact on drug development and the potential for enhanced relationships with regulatory agencies.

Learning objectives

At the conclusion of this short course, participants should be able to:

Describe the risk process
Design a strategy to manage risk throughout the drug development lifecycle including establishing Quality Tolerance limits
Discuss approaches to implementation of a cross functional quality strategy framework that will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle

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R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks throughout the Drug Development Lifecycle

Overview

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Learning objectives

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