Archive: Quality Risk Management in Clinical Trials and Pharmacovigilance

December 10, 2015 | Barnett International Recording

Web Seminar Archives are available in either USB Flash Drive or DVD Format.

Archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

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$735.00

Course Description

The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management.

This web seminar is designed to provide a strong conceptual foundation of the principles of quality risk management with a clear focus on the application of these principles. We will address applying QRM to support decision-making throughout the clinical trial management and pharmacovigilance process, allocating limited resources effectively to areas of high risk, and preparing the participant to become an active contributor towards risk-based quality management at his/her organization.

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Learning Objectives

  • Define Quality Management System (QMS) levels for applicable areas in clinical trials and pharmacovigilance
  • Build quality at key points in the process
  • Apply QRM principles: Identification and quantification of key risk indicators
  • Implement a quality by design approach to overcome shortcomings in quality and compliance
  • Leverage existing information to support decision-making in resource allocation within clinical trials
  • Create a governance model to support mitigation strategies and the overall QMS infrastructure

Who Should Attend

  • Clinical Research, Operations, and Development Professionals
  • Medical Affairs Personnel
  • Safety and Risk Management/Operations Personnel
  • Compliance, Regulatory Affairs, and Clinical Quality Assurance Personnel

Instructor

The course will be led by one of the following instructors:

Randy Ramin-Wright, M.Sc.

Click here for complete trainer biographies

 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.