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Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

Overview: FDA inspections under the new QMSR can look and feel different—not just in what inv..

Date : 23rd February 2026

Time : This Event is Over and the Recorded Content is Available

Duration : 60 Mins

Risk-Based Excel Spreadsheet Validation and FDA Compliance - Risk-Based CSV/CSA & Part 11

Risk-Based Excel Spreadsheet Validation and FDA Compliance - Risk-Based CSV/CSA & Part 11

Overview:FDA inspections and audits continue to put a bright spotlight on data integrity—especiall..

Date : 27th January 2026

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Best Practices for Creating a Clear-Cut Contract and Service Level Agreement (SLA) with a Vendor of Computer Systems Regulated by FDA

Best Practices for Creating a Clear-Cut Contract and Service Level Agreement (SLA) with a Vendor of Computer Systems Regulated by FDA

Overview: Selecting and managing a vendor for computer systems in FDA-regulated environments ..

Date : February 26, 2025

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Quality Management System Regulation (QMSR) – Replacement of QSR and Alignment with ISO

Quality Management System Regulation (QMSR) – Replacement of QSR and Alignment with ISO

Overview: Effective February 2, 2026, FDA’s Quality Management System Regulation (QMSR) became..

Date : 23rd April 2026

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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