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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 : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Supplier Selection and Contract Manufacturer Qualification Under FDA QMSR
Overview: FDA’s QMSR places renewed emphasis on the way medical device companies evaluate, se..
Date : 24th March 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026
Overview: In 2026, data integrity and privacy risks don’t sit in one department—they show up ..
Date : 19th March 2026
Time : This Event is Over
Duration : 90 Mins
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
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
Excel Spreadsheet in FDA Regulated Environment - Validating Excel for GxP & 21 CFR Part 11
Overview: The use of Excel in FDA-regulated environments goes far beyond basic analysis. When ..
Date : 21st November 2025
Time : This Event is Over
Duration : 75 Mins
Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
Overview: Organizations involved in the conduct of human clinical trials must meet rigorous re..
Date : 30th September 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR - 2025
Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..
Date : 21st August 2025
Time : This Event is Over
Duration : 75 Mins
Best Practices in Preparation for an FDA Computer System Audit in 2025
Overview: In 2025, the FDA's expectations for validated computer systems have never been high..
Date : 31st July 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2025
Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding pub..
Date : 27th June 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Sampling Plans for Verification and Validation, Production Process Validation and Production Control
Overview: When design flaws go unnoticed until late in production—or when a batch fails inspe..
Date : 23rd May 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2025
Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..
Date : 11th April 2025
Time : This Event is Over
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
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
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2025
Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and priv..
Date : 14th February 2025
Time : This Event is Over
Duration : 90 Mins
Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance
Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..
Date : 19th November 2024
Time : This Event is Over
Duration : 75 Mins