Search
Products meeting the search criteria
Best Practices for FDA Computer System Audit Preparation in 2026
Overview: For those of us who have worked around FDA-regulated computer systems for many year..
Date : 29th May 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Medical Device Cybersecurity Following FDA’s 2026 Premarket Guidance
Overview Cybersecurity is now a central part of FDA’s review expectations for many connected, ..
Date : 28th May 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
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
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
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 : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
An Advanced Course on Lean Documents, Lean Configuration, and Document Control - What to Know
Overview: In today’s life sciences environment, document control is often where “lean” quietl..
Date : 26th January 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
FDA’s QMSR is Coming: Practical Readiness for Quality Teams
Overview: With the FDA’s Quality Management System Regulation (QMSR) taking effect in February..
Date : 21st January 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 60 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
The 6 Most Common Problems in FDA Software Validation and Verification in 2025
Overview: Professionals working with FDA-regulated software face numerous challenges when it co..
Date : 12th June 2025
Time : This Event is Over
Duration : 75 Mins
Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025
Overview: As regulatory scrutiny intensifies, data integrity and governance have become corne..
Date : 30th May 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 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
Effective Technical Writing for Medical Devices: Improving Your Skills for Clear and Concise Communication
Overview: In the world of medical device manufacturing, technical writing is more than just a..
Date : 27th March 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
US FDA Requirements for Medical Products Labeling / UDI
Overview: The world of medical product labeling in the United States is governed by a complex ..
Date : 10th February 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Preparing a FDA 510(k) submission - What to Know in 2024
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 29th October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins