Key Take Away:
This webinar will provide step-by-step considerations for finding potential vendors, implementing a robust qualification & selection process, strategies for oversight and management of vendors, and a risk mitigation approach for key vendors.
GxPs are required to be followed, not only by the sponsoring company, but also by all vendors who are chosen by the company to complete activities that must follow GxPs. These vendors include, but are not limited to, contract research organizations, clinical investigators, manufacturers of drug substance and drug product used in clinical studies and commercialized, labelers and distributors, testing laboratories, warehouses, and so on.
Why Should You Attend:
In order to ensure selection of vendors who are appropriate to complete the job, companies must have in place a robust program for qualifying vendors, contracting with them, managing and overseeing their activities, and a program for mitigating against risks that may arise related to key vendors.
This webinar will address approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
Areas Covered In This Webinar:
• Making a request for proposal to vendors
• Performing evaluations of vendors
• Auditing potential vendors
• Evaluating business continuity of vendors for long-term relationships
• Establishing comprehensive quality agreements
• Strategy for development of communication plans and oversight activity reviews
• Documenting and monitoring vendor activities
• Value of evaluating back-up vendors
• Step-by-step considerations for finding potential vendors
• Implementing a robust qualification & selection process
• Strategies for oversight and management of vendors
• Risk mitigation approach for key vendors
Who Will Benefit:
• Quality Assurance Personnel
• Quality Control Personnel
• Manufacturing Operations Staff
• Validation Personnel
• Clinical Operations Staff
• Project Management Team
• Regulatory Affairs Personnel
• Non-clinical Study Personnel
Peggy J. Berry
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).
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