概要
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.