Upcoming Webinar
Free Webinar - OSHA Heat Illness Prevention 2026: What HR, EHS and Employers Should Do Now
Scroll to the bottom to watch the entire 30 mi..
Date : May 2026
Time : N/A
Duration : 30 mins
Free Webinar - Remote & Hybrid Work Wage-Hour Risks: Off-the-Clock Work, Overtime, Breaks and Payroll Compliance
Scroll to the bottom to watch the entire 45 mins explainerOverview: Remote and hybrid wo..
Date : May 2026
Time : N/A
Duration : 45 Mins
Free Webinar - OSHA, Burnout and Worker Well-Being: What HR Should Do Before Stress Becomes a Safety Risk
Scroll to the bottom to watch the entire 30 mins explainerOverview Stress, burnout, fati..
Date : May 2026
Time : N/A
Duration : 30 Mins
Free Webinar - FDA Warning Letter on AI Reliance: CGMP Documentation, Quality Unit Review, and Human Accountability
Scroll to the bottom to watch the entire 30 mins explainerOverview Artificial intelligence is ..
Date : June 2026
Time : N/A
Duration : 30 Mins
Excel Spreadsheet Validation in FDA-Regulated Environments
Overview:In an FDA-regulated environment, an Excel spreadsheet may function as a GxP application w..
Date : 12th August 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 require employers to provide paid sick leav..
Date : 18th August 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
Building and Auditing HR Documentation Before Discipline or Termination Is Final
Overview:A professionally written warning, performance improvement plan, investigation summary, or..
Date : 20th August 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins
FMLA Self-Audit: An Employer’s Guide to Proactively Fixing FMLA Compliance Issues
Overview FMLA problems often begin with small process gaps—a manager mishandling an absence, ..
Date : 26th August 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
HR’s Practical Playbook for PWFA, ADA, FMLA, PUMP Act, Leave, Documentation, and Manager Risk
Overview Most employers have a pregnancy accommodation policy. Far fewer have a consistent pr..
Date : 27th August 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
Carolyn Troiano
AI in Drug Development: FDA Compliance, Validation, and Data Integrity
Overview: Artificial Intelligence is no longer sitting at the edge of drug development. It is ..
Date : 24th June 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for FDA Computer System Audit Preparation in 2026
Overview: For those of us who have worked around FDA-regulated computer systems for many year..
Date : 29th May 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Quality Management System Regulation (QMSR) – Replacement of QSR and Alignment with ISO
Overview: Effective February 2, 2026, FDA’s Quality Management System Regulation (QMSR) became..
Date : 23rd April 2026
Time : This Event is Over and the Recorded Content is Available
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 : 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