Upcoming Webinar
Exempt vs, Non-exempt and how the FLSA Defines Each
Overview: The Fair Labor Standards Act (FLSA) continues to be one of the most critical and co..
Date : 21st October 2025
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 60 Mins
New Form 1099 Reporting Requirements: OBBB Changes and 2025 Compliance Update
Overview: If you think you’ve got 1099 reporting figured out, 2025 might change your mind. Wi..
Date : 22nd October 2025
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
FDA’s Q-Submission Program for Medical Devices, Software-in-a-Medical Device Products & SaMD with Considerations for Using AI & ChatGPT
Overview: The U.S. Food and Drug Administration (FDA) has taken a major step toward modernizi..
Date : 22nd October 2025
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
2025 Employee Handbook Updates: Federal, State & Workplace Policy Shifts
Overview: Handbooks are being read differently in 2025. With a new administration resetting p..
Date : 29th October 2025
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
Project Management for CSV in FDA-Regulated Environments (CSA, GAMP®5 2nd Ed.) — with a Brief AI/ChatGPT Overview for PM Support
Overview: Computer System Validation (CSV) has underpinned FDA compliance in regulated industr..
Date : 30th October 2025
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