Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-511-L04-P; CME 3.25; IACET 3.25; RN 3.25
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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.
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.
Back to DIA 2020 Short CoursesWho 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 Describe the risk process;Design a comprehensive quality strategy to manage risk throughout the drug lifecycle;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.
