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Vendor Management Using Quality by Design and Risk Management Strategies
Session Chair(s)
Sherri Ann Hubby
Senior Director, GCP Quality Assurance
Myovant Sciences , United States
Applying Quality by Design and Risk Management Strategies for Selecting Vendors to Perform Trials in Emerging Markets
Learning Objective : Describe how to create and implement a vendor quality management plan which involves understanding the elements of how to properly evaluate risk;Identify risk management tools to contracted vendors to ensure they are appropriately ranked, assessed, and managed according to the frequency of use and level of business and regulatory risk identified;Recognize tools/techniques on how to manage vendors with compliance issues where corrective action taken is not effective.
Speaker(s)
The Advantages of Creating a Vendor Quality Management Plan
Suzanne M. Fink
RPS, Inc., United States
Senior Project Lead, Clinical Data Management
Applying Quality by Design and Risk Management Strategies for Selecting Vendors to Perform Trials in Emerging Markets
Sherri Ann Hubby
Myovant Sciences , United States
Senior Director, GCP Quality Assurance
Third Party Vendor Comprehensive Approach
Kimberly Washburn
Quintiles Transnational Corporation, United States
Senior Director, Quality Assurance
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