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Sunday, June 24 • 8:30am - 12:00pm
#23: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-503-L04-P; CME 3.25; IACET 3.25; RN 3.25

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. An additional registration fee is required for all preconference short courses.
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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



Speakers
avatar for Victoria Burk

Victoria Burk

Director R&D Quality Assurance, AbbVie, Inc.
Vicki Burk is the R&D Quality Assurance director of Combination Products and Medical Devices at AbbVie. She leads a team responsible for Design Quality Assurance and the R&D Combination Product and Device Quality System. Vicki is also the business process owner for the R&D Comprehensive... Read More →
avatar for Kevin Grebner

Kevin Grebner

Director, Clinical Quality Assurance, AbbVie, Inc.
Kevin Grebner is a director in R&D Quality Assurance at AbbVie. Kevin leads the Program Management team responsible for developing and managing the Clinical QA strategy in support of compounds throughout the development life cycle. In his 32 year career at Abbott/AbbVie, Kevin has... Read More →


Sunday June 24, 2018 8:30am - 12:00pm
Room 160A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA