DIA 2022 Global Annual Meeting

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
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
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Upon completion of full meeting registration participants will gain access to the following:

• Live Event Access
• Presentation Slides
  
  Return to DIA 2022 
  
  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
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