Upcoming Webinar
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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
2026 Nacha Rules Changes (Part 1): Fraud Monitoring & Ops Bulletins
Overview: The ACH Network runs on precision—formats, timing, authorizations, monitoring expec..
Date : January 28, 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
Hidden Legal Landmines: Do Your HR AI Tools Meet Regulatory and Audit Requirements?
Overview: As we move into 2026, HR teams are no longer “testing” AI—they’re relying on it for ..
Date : 29th January 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
Legal Landmine Ahead: Why Your Company's Fitness Trackers May Violate EEOC Guidelines
Overview: On December 19, 2024, the EEOC published a fact sheet, “Wearables in the Workplace:..
Date : 29th January 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
José Mora
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
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
An Advanced Course on Lean Documents, Lean Configuration, and Document Control in 2024
Overview: In today's fast-paced life sciences industry, many companies struggle with cumberso..
Date : 20th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Overview: 21 CFR Part 820 delineates the Quality System Regulation (QSR) that governs all ent..
Date : 23rd July 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
How to Conduct a Human Factors Usability Validation for Medical Device Products
Course Level: IntermediateOverview:Human Factors/ Usability is the analysis of how people interact ..
Date : 08th Feb 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
An Advanced Course on Lean Documents, Lean Configuration, and Document Control
Overview:Just as a manufacturing process produces a product, controlled documents are the product o..
Date : 13th July 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 1 Hour 30 Mins
Risk-based Design Control - The New Paradigm for Medical Device Design
Overview: Risk management overarches projects associated with a particular product family, giv..
Date : 17th February 2022
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 10 Mins
21 CFR Part 820 - Quality System - Principles of Lean Documents and Lean Configuration
Overview: All life science businesses are required to maintain their Quality Management Syste..
Date : 21st September 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 30 Mins
Risk Management for Medical Devices per ISO 14971:2019
Overview: Risk management overarches projects associated with a particular product family, gi..
Date : 11th August 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 19 Mins
Software Validation Utilizing Principles of Lean Documents and Lean Configuration
Overview: All life science businesses are required to maintain their Quality Management System..
Date : 10th June 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 90 Mins
IEC 62304 for Medical Device Software - Is your Medical Device Software Out of Compliance?
Overview:This course is essential for Medical Device companies interested in submitting software e..
Date : 23rd March 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 70 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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins