Selection and Management of Contract Vendors

Why Should You Attend:

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.

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 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.

Areas Covered in the 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

Who Will Benefit:

This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to working with external vendors for GxP activities:

• Quality Assurance
• Quality Control
• Manufacturing Operations
• Validation
• Clinical Operations
• Project Management
• Regulatory Affairs
• Non-clinical Study Personnel

Peggy Berry
Founder, Synergy Consulting LLC

Peggy J. Berry, MBA, RAC, is the president and 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). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held regulatory affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).

In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

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