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10: RegCMC-Product Quality [clear filter]
Sunday, June 23
 

9:00am

SC28: #28: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

Quality oversight of drugs throughout the product development lifecycle is complex and crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way. This short course will begin with a brief review of ICH E6 (R2) and the impact to the clinical development enterprise. The group will then examine points to consider regarding the principles and benefits of a quality management framework as a foundation in setting tolerance limits, managing issues, identifying and mitigating risks, and applying analytics as part of quality risk management. Through hands-on experience with hypothetical case studies developed for this course, you will design a proactive approach for the identification and management of quality risks and issues; develop thresholds for triage thereby setting tolerance limits; and experience design trending leading to analytics to identify future signals and risks. You will leave with knowledge and access to materials that will enable you to design a framework for identification and mitigation of quality risks as well as management of issues with tolerance limits which could reside in your own organization’s risk management program.
The instructors will take you through the development of a cross functional quality strategy frame work 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. 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.
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe the risk process;
  • Design a comprehensive quality strategy to manage risk throughout the drug lifecycle and establish Quality Tolerance Limits and Issue Management;
  • Discuss ways to implement a cross functional quality strategy frame work to identify, manage, and communicate quality risks across the R&D GxP functions.



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 →
avatar for Tim Grey

Tim Grey

Director,R&D Quality Systems, AbbVie, Inc.
Tim Grey joined AbbVie in December 2013. He is currently Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team. Tim has spent his career developing, applying, and implementing quality systems principles across the GxP product... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA