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Overview

Quality oversight of drugs throughout the product development lifecycle is complex, crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way. This short course takes you through the development of a cross functional quality strategy frame work in an R&D QA organization which, when implemented will coordinate, communicate, and manage quality risks along with business partners throughout the life of a drug product. Using a “Playbook and Game Plan” analogy, we will workshop real-life examples of the quality gates that a drug in development needs to pass through to assure confidence in the quality of the data for submission to regulatory agencies for approvals. The effect and value of this approach will be shown, revealing the positive impact on drug development and the potential for enhanced relationships with regulatory agencies.

Who should attend?

This short course is designed for professionals within sponsor, CRO, and regulatory agency organizations interested in research and development, clinical research, and/or clinical quality assurance.

Learning objectives

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

  • Analyze the positive effect that a cross functional quality strategy (CQS) has on a drug in the development pipeline
  • Identify the framework for a CQS and workshop examples of quality risk mitigations
  • Describe how CQS optimizes quality as a competitive advantage in delivering safe/effective drugs

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