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Overview

Are you ready for ICH E6 (R2)? Have you defined your Quality Tolerance Limits? This highly interactive short course with hands on experience will apply the TransCelerate Issue Management Conceptual Framework as a foundation in setting tolerance limits, managing issues, and applying analytics as part of quality risk management.

The short course will begin with a quick review of ICH E6 R1, R2, and the impact to the clinical development enterprise. Following the review, instructors will provide points to consider regarding the principles and benefits of a framework with a proactive approach for end to end management of issues including a triage mechanism (tolerance limits) that is utilized to drive continuous improvement and supports the management of risk.

Using hypothetical case studies (developed for this course) you will begin with designing a proactive approach for the management of issues. TransCelerate tools developed during a 24 month journey with a cross function team from pharma industry participating in a TransCelerate Clinical QMS Initiative for Issue Management will be available and utilized for this exercise. Through this hands on experience, you will develop thresholds for triage thereby setting tolerance limits in the hypothetical cases. Next, you will have the experience of developing CAPAs that make a difference and design trending leading to analytics to identify future signals and risks. Lastly you will have an opportunity to learn from the instructor’s approaches to getting started in their institutions.

In 3.5 hours, you will leave with knowledge and access to material developed that will enable you to design a framework for management of issues with tolerance limits which could reside in your own organization’s risk management program.

Who should attend?

This short course is designed for Clinical Development team members involved in risk Mgmt., developing risk tolerance and issue Mgmt. at the site, trial, or program level, study monitors, trial managers/specialists, clinical operations personnel or functions involved in the design, implementation, execution, & reporting of clinical activities associated with human research/clinical development, study coordinators/managers, GCP quality/compliance

Learning objectives

At the conclusion of this course, participants should be able to:

  • Implement a framework in which issues are managed, tolerance limits are defined and resulting data can be leveraged to detect new signals/risks and drive continuous improvement
  • Formulate tolerance limits through a proactive issue management framework
  • Define methodology for trending and analytics that will signal potential risks.

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