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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
Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304
Overview: In the fast-evolving field of medical technology, ensuring the safety and efficacy ..
Date : 28th May 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Good Documentation Practices to Support FDA Computer System Validation
Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..
Date : 29th March 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration
Overview: Medical device and life science organizations are expected to maintain a Quality Ma..
Date : 20th February 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
Storytelling in Project Management for Validating FDA-Regulated Computer Systems: How to Captivate & Inspire the Team
Overview: Validating FDA-regulated (“GxP”) computer systems often stalls for reasons that have..
Date : 25th February 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins