Name: QUALITY TRACK: Quality at the Site Level
Start: 2024-09-26T13:45:00-0400
End: 2024-09-26T14:15:00-0400

Thursday September 26, 2024 1:45pm - 2:15pm EDT

Sponsor Review of Monitoring Visits and TMF Oversight for FDA Inspections

Learn successful site-specific strategies for a proactive approach to FDA inspections
Get an in-depth understanding of an FDA inspection and post-inspection activities for sites and sponsors
Gain valuable insight from a sponsor Standard Operating Procedural perspective while examining the TMF/site information to stay “inspection ready
Understand best practices to assure study integrity and GCP compliance

Speakers

Lella Baker

Senior Consultant, GxP, Advarra

Lella Baker is a quality-minded professional with over 15 years of pharmaceutical and medical device experience. Lella has expertise in conducting vendor qualification and requalification audits, internal audits and ISA audits. She has completed regulatory filings for ADE drug safety... Read More →

Thursday September 26, 2024 1:45pm - 2:15pm EDT

Clinical Quality Track

Qtag clinicalqualityfeaturedsession

Fierce Clinical Summit 2024

Lella Baker

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