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Boston Convention and Exhibition Center

2013年6月23日 (日) 午前 8:30 - 2013年6月27日 (木) 午後 12:45

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Vendor Management Using Quality by Design and Risk Management Strategies

Session Chair(s)

Sherri Ann Hubby

Sherri Ann Hubby

Director, Clinical Quality Assurance

Vera Therapeutics, 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)

Suzanne M. Fink

The Advantages of Creating a Vendor Quality Management Plan

Suzanne M. Fink

RPS, Inc., United States

Senior Project Lead, Clinical Data Management

Sherri Ann Hubby

Applying Quality by Design and Risk Management Strategies for Selecting Vendors to Perform Trials in Emerging Markets

Sherri Ann Hubby

Vera Therapeutics, United States

Director, Clinical Quality Assurance

Kimberly  Washburn

Third Party Vendor Comprehensive Approach

Kimberly Washburn

Quintiles Transnational Corporation, United States

Senior Director, Quality Assurance

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