Upcoming Webinar
Free Employer Guide to the FY 2027 H-1B Cap Season: Registration, Filing, Compliance & Real-World HR Scenarios
Scroll to the bottom to watch the entire 90 mins webinarOverview The FY 2027 H-1B cap season i..
Date : March 2026
Time : N/A
Duration : 1 Hour 45 Mins
Supplier Selection and Contract Manufacturer Qualification Under FDA QMSR
Overview: FDA’s QMSR places renewed emphasis on the way medical device companies evaluate, se..
Date : 24th March 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
Mandatory Paid Sick Leave Breaking Through the Quagmire and Quandary of Compliance in 2026
Overview: Many states and the District of Columbia now require employers to provide paid sick ..
Date : 25th March 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
The ABC’s of ACH Returns | Stop Payments, Unauthorized Returns & Nacha Rules
Overview: ACH returns remain one of the most confusing and operationally sensitive areas of A..
Date : 26th March 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins
2026 Employee Handbook Update & Policy Audit for Multi-State and Remote Employers
Overview Employee handbooks have become one of the most important — and most misunderstood — ..
Date : 27th March 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 180 Minutes
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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
California Wage and Hour Laws 2026: New Rules, Overtime, Pay, Leave and Compliance
Overview: California employers do not usually get into trouble because they ignore the law ent..
Date : 09th April 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
Carolyn Troiano
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 : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Transition from CSV to CSA; FDA Final CSA Guidance, September 2025 for Medical Device Manufacturing & Quality Testing
Overview: For decades, life-science teams have relied on Computer System Validation (CSV)—sha..
Date : 21st November 2025
Time : This Event is Over and the Recorded Content is Available
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 : This Event is Over and the Recorded Content is Available
Duration : 90 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 : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
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