Upcoming Webinar
Employee Terminations: Avoiding Costly Mistakes Before, During and After Dismissal
Overview: An employee termination may take only a few minutes, but the consequences of a poor..
Date : 05th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
The 6 Most Common FDA Software Validation Failures and How to Prevent Them
Overview: One of the most concerning findings during an FDA inspection is discovering that an ..
Date : 10th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
FDA Biocompatibility in 2026: What to Test, What to Justify, and What to Submit
Overview A medical device can undergo extensive biocompatibility testing and still encounter ..
Date : 16th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins
Employee Attendance and Medical Restrictions: When to Accommodate, Discipline or Terminate
Overview: An employee has accumulated enough attendance points for a final warning. The super..
Date : 17th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins
Paid Leave and PTO Compliance in 2027: State Changes, Payroll Taxes and Policy Updates
Overview An employer can offer more PTO than the law requires and still have a paid leave com..
Date : 18th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
2026 Form W-2 Update: Overtime, Tips, Reconciliation and Year-End Reporting
Overview Preparing W-2s has always required careful year-end review, but 2026 brings new repor..
Date : 19th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 60 Mins
José Mora
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
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