Webinar recording:

How to Get the Best from Supplier Audits

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A webinar for clinical trial sponsors and service providers

Recorded November 3, 2021

Hear expert advice and innovative solutions from a panel of experienced auditors and learn how to avoid problems and delays in vendor qualification assessments.

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 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.

This webinar is for:

  • QA and Compliance Directors at trial sponsors
  • Service providers
  • Quality auditors

⭐⭐⭐⭐ 78% of viewers rated this webinar as Good or Very Good

Very InformativeAssociate Director, GXP Audits, Pharma Very informational! Thank you!Associate Director, Quality Audits, Biotech Great webinar. Thank you! – Project Leader, Consulting Excellent webinar and speakersQualification and Metrology Manager, Pharma

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Hear honest advice from our expert panel of clinical research quality auditors

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.

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.

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.

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.

Key Learning Objectives

  • Hear the challenges faced in qualifying service providers and problems to avoid
  • Learn snags and time-burners that both trial sponsors and vendors need to know
  • Discover 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

Questions from our audience

Our panel’s responses to these questions are on the next page or can be heard during the webinar recording – access it here!

  • Pre/Post Covid Impact: What are some of the differences between how to conduct on-site versus virtual audits?
  • Are there any specific topics or functional area(s) which are frequently more vulnerable to risk than other areas?
  • Why should Quality be responsible for qualifying GCP suppliers? How would you sell this to your organization/sponsors?
  • At what stage in a start up biotech company do I need to audit my vendors? We are only in phase 1.
  • Typically, how long would you spend on preparation prior to performing a vendor audit?
  • For a vendor qualification audit, so with no actual work done, would you request access to [a vendor’s] systems?
  • Is it required to audit vendors annually? Can we define a different frequency and what aspects should we consider to decide this?
  • I’m interested in tips on making remote audits more efficient, and identifying good questions to ask on a phone call
  • Would you go into discussion on any kind of observation, and how to handle this during the audit performance?
  • How long does it take on average to qualify a new Vendor?
  • What key checks do you look for with cloud vendors to verify data integrity?
  • How do you handle a language barrier where the vendor predominantly doesn’t speak or have documents in English?
  • What is the best way during qualification to ensure that vendor subcontractors are qualified/have sufficient oversight? Is the sponsor required to be notified of all subcontractors?

For more details or a free demo of the Diligent Qualification Platform