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Wednesday, June 15 • 10:00am - 1:00pm
32A: 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 2.75 Application UAN: 0286-0000-22-506-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

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.




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1.888.257.6457 Registration Info Rate: $350
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Upon completion of full meeting registration participants will gain access to the following:
  • Live Event Access
  • Presentation Slides

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    Who should attend?

    This short course is designed for members involved in Clinical Quality Assurance, R&D Quality Assurance, Clinical operations, Clinical Auditees, and Inspection Management.

    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



Speakers
avatar for Matt Burtt

Matt Burtt

Director Clinical QA, AbbVie, United States
After completing a Biomedical Engineering undergraduate degree, I built upon my internship with Abbott (eventually AbbVie) in a 2 year rotational program with different assignments every six months across the business landscape. Since then I've been in the R&D Quality Assurance world... Read More →
avatar for Arun Mathew

Arun Mathew

Associate Director, Abbvie, United States
Business process owner for quality risk management in R&D(2.6yrs) Risk Management experience(19 yrs.) Medical devices experience (16yrs). Contributed and reviewed the book Foundations of Quality Risk Management.


Wednesday June 15, 2022 10:00am - 1:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   08: RD Quality-Compliance, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial