How to Get the Best from Supplier Audits

An Interactive Session for Clinical Trial Sponsors, CROs, Service and Technology Providers

Presented by:

  • Free

Why attend?

The due diligence and selection process of service providers may seem daunting to vendor and quality management teams, especially with the coordination of a wide array of specialty vendors and all the contracts that go with them while operating under Good Clinical Practices (GCP).

Any one vendor can introduce risk to the entire study, its patients, or results. Today’s sponsor must have a philosophy as well as clear procedures to develop and implement a risk-based approach to vendor GCP qualification and auditing.

Join us for a roundtable discussion where a panel of experienced auditors will share their expert advice and innovative solutions that avoid problems and help both clinical trial Sponsors and Vendors to manage and prepare for vendor qualification assessments.

Accelerate the startup of your next clinical trial with innovations in the vendor qualification process to minimize critical findings, delays and the resources required by your organization.

Key Learning Objectives

  • Challenges faced in qualifying service providers and problems to avoid
  • Snags and time-burners that both trial sponsors and vendors need to know
  • How to prioritize strategically and leverage third parties so internal resources can focus on areas with the highest business risks
  • Learn from the minds of auditors who are knowledgeable and experienced in local regulations throughout the globe

Speakers

Select a speaker to learn more

Jennifer Sessions
Senior Director, Diligent Pharma

Jennifer has over 20 years of experience in clinical research, mostly with Eli Lilly and Company. Most recently, she served as the CEO of Cynvec, a private biotech company focused on cancer therapies. She has a Six Sigma Black Belt certification and is based in Charleston, South Carolina.

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Joseph Schenk
CEO at Quality Bridge

Joseph has over 30 years of quality improvement, computer validation and project management experience working for FDA regulated (GxP) processes. He has conducted 175+ audits of CROs, software vendors and other GxP suppliers.

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Mary Mackney
QA Consultant, Pharma QA

Mary is a qualified pharmacist and previously managed the Clinical Trial Supplies and QA divisions for British Biotech. She set up Pharma QA, a GxP Quality Assurance consulting firm based in the UK in 2003.

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Stephen Gilbride
President of SG Research International (SGRI)

Stephen began his career with Pfizer in New York in 1990 and he has extensive global drug development experience, particularly as it pertains to Good Clinical Practices.
Stephen has made a positive impact on both small and mid-size biotech companies, championing the quality environment and leading to successful submissions.

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