34th SQA Annual Meeting and Quality College: Session Y

The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please note that Quality College workshops require separate registration.

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Session Y - Roundtables Track

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Y-1 Remote or Multisite Vendor Auditing - Perspectives from a Sponsor and a CRO

Abstract:
Summary – With subcontracting being the new normal and companies looking at overall efficiencies and cost savings, is there a way to oversee your Vendors without traveling all across the world?
Remote and Multi-site vendor auditing may be the solution for you, but when is it most appropriate to undertake these types of audits. As a Sponsor, how does one go about conducting an effective remote or multi-site audit? As a Vendor, how does one accommodate these audits? What are the benefits, challenges and deficiencies with these types of audits.
This presentation will give answers to these questions from both the Sponsor and CRO perspective.

Category:
Beyond Compliance

Level of Content:
Intermediate

Moderators

James Farmer

Sr. Manager, Regulatory Compliance, Charles River

James Farmer is the Sr. Manager, Regulatory Compliance at Charles River Laboratories – Nevada, a safety assessment site conducting GLP studies. In this role he is responsible for the Quality Program of the Nevada facility to include overseeing various projects such as Regulatory... Read More →

Speakers

Carla Buckley

Charles River Laboratories Nevada

Sherry Lee Dawson

Manager, Regulatory Compliance, Charles River Laboratories Montreal ULC

Sherry Lee Dawson, is a Quality Assurance Manager at Charles River Laboratories Montreal ULC, a safety assessment site conducting GLP studies. In this role she oversees various projects, including Regulatory Inspections, Sponsor Audits, Vendor Audit program for her site, quality metrics... Read More →