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Medical Device Hazard Analysis Under FDA QMSR: A Practical ISO 14971 Guide
OverviewHazard analysis has always played an important role in medical device safety. Under FDA’s ..
Date : 25th August 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Disability Accommodations and the Interactive Process: Reasonable Accommodations in the Modern Workplace
Overview: Disability accommodation requests have become one of the most difficult areas of wor..
Date : 30th July 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
CAPA Under QMSR: Root Cause, Risk, and Effectiveness Verification
Overview: CAPA is one of the most closely examined parts of a medical device quality system, ..
Date : 23rd July 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Workplace Negativity: How HR and Managers Can Stop It Early
Overview Workplace negativity is often treated as a “people problem,” but HR professionals kno..
Date : 23rd June 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
The FMLA in 2026: Employer Compliance, Intermittent Leave, and Managing Suspected Abuse
Overview:Managing FMLA leave in 2026 is rarely as simple as approving 12 weeks of unpaid leave and ..
Date : 10th June 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 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
HR Documentation: How Can HR Professionals and Supervisors Create Litigation-Proof Decisions in 2026
Overview: Employee documentation continues to be one of the most sensitive and mishandled area..
Date : 31st March 2026
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 : 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
FDA Human Factors Usability Guidance | ISO 62366 & Draft Update Explained
Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..
Date : 29th May 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Minutes
HR Documentation: How Can HR Professionals and Supervisors Create Litigation Proof Decisions in 2025
Overview: In the fast-paced world of human resources, documentation isn't just about keeping ..
Date : 25th April 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Overview: Test Method Validation (TMV) is a critical yet often misunderstood requirement in t..
Date : 21st October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024
Overview: In the world of medical device development, the US FDA places a high priority on ri..
Date : 14th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance
Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..
Date : 25th June 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins