Upcoming Webinar
Employee Terminations: Avoiding Costly Mistakes Before, During and After Dismissal
Overview: An employee termination may take only a few minutes, but the consequences of a poor..
Date : 05th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
The 6 Most Common FDA Software Validation Failures and How to Prevent Them
Overview: One of the most concerning findings during an FDA inspection is discovering that an ..
Date : 10th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins
FDA Biocompatibility in 2026: What to Test, What to Justify, and What to Submit
Overview A medical device can undergo extensive biocompatibility testing and still encounter ..
Date : 16th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins
Employee Attendance and Medical Restrictions: When to Accommodate, Discipline or Terminate
Overview: An employee has accumulated enough attendance points for a final warning. The super..
Date : 17th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins
Paid Leave and PTO Compliance in 2027: State Changes, Payroll Taxes and Policy Updates
Overview An employer can offer more PTO than the law requires and still have a paid leave com..
Date : 18th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
2026 Form W-2 Update: Overtime, Tips, Reconciliation and Year-End Reporting
Overview Preparing W-2s has always required careful year-end review, but 2026 brings new repor..
Date : 19th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 60 Mins
Carolyn Troiano
Responding to FDA Form 483 Observations: What FDA Expects in 2026
Overview: Receiving a Form FDA 483 at the conclusion of an inspection can put an organization ..
Date : 28th October 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Audit Trail Review by Exception in FDA-Regulated Environments: Reducing Review Burden While Strengthening Data Integrity
Overview Audit trails are essential to maintaining trustworthy electronic records in FDA-regu..
Date : 28th August 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 90 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 : 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