#41: Quality Oversight of CROs-Clinical Vendors Day & Time:
June 15, 9:00AM - 5:00PM (Pacific Standard Time)Room Number:
Liz Wool, BSN, RN
President and Chief Executive Officer
QD-Quality and Training Solutions Inc., United States
Jennifer J Poulakos,
Director, Development Quality Assurance
Agensys, Inc, United States
Senior Manager, Supplier Governance
Amgen Inc., United StatesDescription:Maximize your learning while attending the DIA 2014 50th Annual Meeting! Receive $100 off of your DIA 2014 meeting registration by registering for two half-day tutorials or one full-day tutorial. Purchases must be made at the same time in order to receive the discount.
FDA and EMA communicate at industry conferences, FDA-CTTI meetings, and regulatory agency public meetings. Sponsors and CRO-vendors who are transferred the responsibilities for trial conduct must have in place a vendor management-oversight program and methods, as well as a quality management system and risk management framework for the execution of clinical trials. Building upon this framework and benchmarking to ISO-9001: 2008, Quality Management Systems, this tutorial describes Quality Oversight of Vendors, with the focus on quality management systems, risks associated with outsourcing and approaches for early identification of risks to support adequate oversight, quality attributes, and performance monitoring.
|#41: Quality Oversight of CROs-Clinical Vendors ||IACET||6.50||0.700|
At the conclusion of this tutorial, participants should be able to:
• Discuss quality management systems principles and methods, and the criticality for early risk identification with a CRO clinical vendor in order to execute adequate vendor oversight;
• Identify two key elements of an internal communication plan for vendor oversight that supports both business and team successes;
• Identify two metrics for utilization when outsourcing a clinical trial to a vendor.
This tutorial is designed for professionals involved in clinical research, clinical operations, outsourcing, regulatory affairs, quality compliance, project management and commercial-medical affairs, Sponsors, CROs, ACROs, AROs, as well as personnel from the NIH, DoD, and VA will also find this tutorial valuable.