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
Carolyn Troiano
Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
Overview: Organizations involved in the conduct of human clinical trials must meet rigorous re..
Date : 30th September 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)
Overview: Life science industries — including pharmaceutical, medical device, biotechnology, ..
Date : 11th September 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices in Preparation for an FDA Computer System Audit in 2025
Overview: In 2025, the FDA's expectations for validated computer systems have never been high..
Date : 31st July 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 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
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
FDA Guidance for Use of Social Media by Regulated Industries
Overview: In the early days of social media, regulatory agencies were observers — watching as..
Date : 30th April 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for Creating a Clear-Cut Contract and Service Level Agreement (SLA) with a Vendor of Computer Systems Regulated by FDA
Overview: Selecting and managing a vendor for computer systems in FDA-regulated environments ..
Date : February 26, 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)-
Overview: As the life sciences industry, encompassing pharmaceuticals, medical devices, biotech..
Date : 13th January 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins + Q&A
Functional and System Requirements for Systems Regulated by FDA in 2024
Overview: The validation of computer systems (CSV) under FDA regulations has shaped the way e..
Date : 25th November 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA
Overview: Conducting human clinical trials requires strict adherence to government regulatory ..
Date : 30th October, 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024
Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding p..
Date : 30th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices in Preparation for an FDA Computer System Audit in 2024
10 Minutes excerpt from the recorded event for your review: Best Practices in Preparation for a..
Date : 22nd July 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments
10 Minutes excerpt from the recorded event for your review: Read the LinkedIn Article: Lin..
Date : 28th June 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
10 Minutes excerpt from the recorded event for your review:Read the LinkedIn Article: LinkedIn ..
Date : 30th May 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices
Overview The landscape of computer system validation is undergoing a transformative shift wit..
Date : 30th April 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins