Quality Oversight of CROs-Clinical Vendors
June 23 from 9:00AM – 5:00PM in Boston
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 systems, quality attributes, and performance monitoring.
Instructor(s):
Liz Wool, BSN,RN
President and Chief Executive Officer
QD-Quality and Training Solutions Inc., United States
Jennifer J Poulakos, PhD
Director, Clinical Quality Assurance
Astellas, United States
Jeffery Baldwin, BSN,RN
Senior Manager, Supplier Governance
Amgen, United States
What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.
Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.
Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
June 23 from 9:00AM – 5:00PM in Boston
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 systems, quality attributes, and performance monitoring.
Instructor(s):
Liz Wool, BSN,RN
President and Chief Executive Officer
QD-Quality and Training Solutions Inc., United States
Jennifer J Poulakos, PhD
Director, Clinical Quality Assurance
Astellas, United States
Jeffery Baldwin, BSN,RN
Senior Manager, Supplier Governance
Amgen, United States
What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.
Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.
Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
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