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
Workplace Negativity: How HR and Managers Can Stop It Early
Overview Workplace negativity is often treated as a “people problem,” but HR professionals kno..
Date : 23rd June 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
Before You Terminate or Lay Off an Employee: Documentation, WARN, Retaliation, and Communication Mistakes HR Must Avoid
Overview: Employee terminations and layoffs are among the most difficult and high-risk decisio..
Date : 24th June 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
CAPA Under the FDA QMSR: Corrective Action, Preventive Action, and Inspection Readiness
Overview: Under the FDA’s new Quality Management System Regulation, CAPA is no longer somethin..
Date : 25th June 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
Filed Late, Filed Wrong, or Not Filed at All: What Every Employer Must Know About EEO-1 and Pay Data Reporting in 2026
Overview: The EEO-1 report has long been one of the most misunderstood compliance obligations ..
Date : 30th June 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
When Leave Raises Red Flags: Managing and Preventing Abuse Under FMLA, ADA & Workers’ Comp
Overview: Every questionable leave case creates two records. The first is the one you th..
Date : 30th June 2026
Time : 3:00 PM Eastern Time / 12:00 PM Pacific Time
Duration : 90 Mins
Carolyn Troiano
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
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