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Webinars

AI Governance & CSA in Practice: How to Validate AI in GxP Environments
May 5, 2026 11 AM to 12 PM ET

AI Governance & CSA in Practice: How to Validate AI in GxP Environments

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AI Governance & CSA in Practice: How to Validate AI in GxP Environments
May 5, 2026 11 AM to 12 PM ET
Upcoming Events

AI Governance & CSA in Practice: How to Validate AI in GxP Environments

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CSA in the Era of QMSR: How FDA’s New Regulation Redefines Assurance Expectations
February 26, 2026 11:00AM to 11:45AM ET

CSA in the Era of QMSR: How FDA’s New Regulation Redefines Assurance Expectations

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FDA Final CSA Guidance Released
Nov 13, 2025, 11:00 AM – 12:30 PM ET

FDA Final CSA Guidance Released

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Accelerating validation with credibility and confidence
November 12, 2025 10 AM ET
CSA/CSV

Accelerating validation with credibility and confidence

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Mastering Risk-Based Approaches in CSV & CSA Compliance
November 5, 2025 11:00 AM - 12:15 PM ET
CSA/CSV

Mastering Risk-Based Approaches in CSV & CSA Compliance

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AI for Process Optimization: How to Improve Manufacturing Efficiency
September 17, 2025 11:00AM – 12:15 PM ET
Regulatory

AI for Process Optimization: How to Improve Manufacturing Efficiency

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AI Governance in MedTech: Experts Insights
August 27, 2025 11:00 AM to 11:45 AM ET
Regulatory

AI Governance in MedTech: Experts Insights

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AI Governance Strategic Imperative in MedTech
August 7, 2025 11:00 AM to 11:45 AM ET
CSA/CSV

AI Governance Strategic Imperative in MedTech

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Next-Gen Digital Validation: Enabling CSA with AI
June 18,2025 11:00AM to 11:45AM ET
CSA/CSV

Next-Gen Digital Validation: Enabling CSA with AI

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Digital pFMEA: Proactive Manufacturing Risk Management and Alerting
May 21st 2025, 11:00 AM - 11:30 AM ET
Polarion

Digital pFMEA: Proactive Manufacturing Risk Management and Alerting

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Digitalizing Design Quality: Realizing Value- Implementation & Adoption
March 27, 2025 11:00 AM ET
CSA/CSV

Digitalizing Design Quality: Realizing Value- Implementation & Adoption

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Digitalizing Design Quality – Business Case
December 12, 2024 10:00 AM to 10:45 AM ET
CSA/CSV

Digitalizing Design Quality – Business Case

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Preparing for FDA Inspections in a Digitalized Landscape: A CSA Perspective
November 19, 2024 11:00 AM to 12:15 PM ET
CSA/CSV

Preparing for FDA Inspections in a Digitalized Landscape: A CSA Perspective

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Transforming Software Validation with the Agile CSA
October 17, 2024 11:00 AM to 12:15 PM ET
CSA/CSV

Transforming Software Validation with the Agile CSA

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Where Are You with Your CSA
October 2, 2024 11: 15 AM ET
CSA/CSV

Where Are You with Your CSA

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CSA for Cloud-Based and Third-Party Software Solutions
September 23, 2024 11:15 AM ET
CSA/CSV

CSA for Cloud-Based and Third-Party Software Solutions

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Navigating Complex Software Deployments and Organizational Change Management
June 25, 2024 1: 30 PM - 2:15 PM ET
OCM

Navigating Complex Software Deployments and Organizational Change Management

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Digital Transformation: The Alcon Experience – Stage 3: Adoption
June 18, 2024 1:00 PM ET
OCM

Digital Transformation: The Alcon Experience – Stage 3: Adoption

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Digital Transformation: The Alcon Experience – Stage 2: Adaption
June 4, 2024 1: 00 PM ET
OCM

Digital Transformation: The Alcon Experience – Stage 2: Adaption

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Digital Transformation: The Alcon Experience – Stage 1: Acknowledgement
May 21, 2024 1: 00 PM ET
OCM

Digital Transformation: The Alcon Experience – Stage 1: Acknowledgement

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Identifying Data Integrity Lapses in the QC Laboratory
May 9, 2024 11:00 AM to 12:00 PM ET
CSA/CSV

Identifying Data Integrity Lapses in the QC Laboratory

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Digital Transformation: Cause, Catalyst, or Chaos?
May 7, 2024 1: 00 PM ET
OCM

Digital Transformation: Cause, Catalyst, or Chaos?

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Integrated Compliance: Synergy between GxP and Other Regulatory Requirements
April 30, 2024 11:00 AM - 12:00 PM ET
CSA/CSV

Integrated Compliance: Synergy between GxP and Other Regulatory Requirements

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Enabling Advanced Manufacturing (Industry 4.0) with Digital CSA
February 20, 2024 10: 00 AM ET
CSA/CSV

Enabling Advanced Manufacturing (Industry 4.0) with Digital CSA

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Digital Agile CSA | What does GAMP 5 Second Edition say?
July 24, 2023 12: 30 PM ET
CSA/CSV

Digital Agile CSA | What does GAMP 5 Second Edition say?

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Automating Computer Software Assurance Risk Management – Perspectives from BD
April 25, 2023 11: 00 AM ET
CSA/CSV

Automating Computer Software Assurance Risk Management – Perspectives from BD

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Organizational Change Management CSA Success Story – Season 4, Episode-2
March 14, 2023 11: 00 AM ET
CSA/CSV

Organizational Change Management CSA Success Story – Season 4, Episode-2

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FDA thinking the scope & application of 21 CFR Part 11 – Season 4, Episode-1
February 7, 2023 11: 00 AM ET
CSA/CSV

FDA thinking the scope & application of 21 CFR Part 11 – Season 4, Episode-1

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FDA’s Draft Guidance: Computer Software Assurance Webinar Series Season 3, Episode-9
November 11, 2022 10: 00 AM ET
CSA/CSV

FDA’s Draft Guidance: Computer Software Assurance Webinar Series Season 3, Episode-9

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FDA’s Draft Guidance: CSA Webinar Series Season 3, Episode-8
November 4, 2022 10: 00 AM ET
CSA/CSV

FDA’s Draft Guidance: CSA Webinar Series Season 3, Episode-8

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FDA’s Draft Guidance: CSA Webinar Series Season 3, Episode-7
October 28, 2022 10: 00 AM ET
CSA/CSV

FDA’s Draft Guidance: CSA Webinar Series Season 3, Episode-7

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FDA’s Draft Guidance: Computer Software Assurance Webinar Series Season 3, Episode-6
October 21, 2022 10: 00 AM ET
CSA/CSV

FDA’s Draft Guidance: Computer Software Assurance Webinar Series Season 3, Episode-6

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FDA’s Draft Guidance: Computer Software Assurance Webinar Series Season 3, Episode-5
October 14, 2022 10: 00 AM ET
CSA/CSV

FDA’s Draft Guidance: Computer Software Assurance Webinar Series Season 3, Episode-5

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FDA’s Draft Guidance: CSA Webinar Series Season 3, Episode-4 – Identifying the Intended Use
October 7, 2022 10: 00 AM ET
CSA/CSV

FDA’s Draft Guidance: CSA Webinar Series Season 3, Episode-4 – Identifying the Intended Use

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FDA’s CSA Draft Guidance Season 3, Episode 3 – CSA Risk Framework
September 30, 2022 10: 00 AM ET
CSA/CSV

FDA’s CSA Draft Guidance Season 3, Episode 3 – CSA Risk Framework

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CSA Season 3, Episode 2: FDA’s CSA draft guidance 2022
September 20, 2022 12: 00 PM ET
CSA/CSV

CSA Season 3, Episode 2: FDA’s CSA draft guidance 2022

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FDA’s CSA Guidance to Data Integrity
March 24, 2022 01: 30 PM ET
CSA/CSV

FDA’s CSA Guidance to Data Integrity

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Accelerate Your Industry 4.0 Strategy with CSA
January 27, 2022 12: 00 PM ET
CSA/CSV

Accelerate Your Industry 4.0 Strategy with CSA

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Computer Software Assurance Revolution Season 2, Episode 6: Risk Based Approach & FMEA
August 17, 2021 11: 30 AM ET
CSA/CSV

Computer Software Assurance Revolution Season 2, Episode 6: Risk Based Approach & FMEA

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Free Webinar on Polarion CSA: Transform CSV Using Polarion Computer Software Assurance
July 27, 2021 12:30 PM EDT
Polarion

Free Webinar on Polarion CSA: Transform CSV Using Polarion Computer Software Assurance

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CSA Revolution Season 2, Episode 5: Computer Software Assurance Fast Pass to Automation
May 31, 2021
CSA/CSV

CSA Revolution Season 2, Episode 5: Computer Software Assurance Fast Pass to Automation

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Computer Software Assurance Revolution: Season 2, Episode 4 Transform Software Defects
April 22, 2021 11: 00 AM ET
CSA/CSV

Computer Software Assurance Revolution: Season 2, Episode 4 Transform Software Defects

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FDA Part Two – Data Integrity: The Challenges & CSA Application
March 16, 2021 12: 00 PM ET
CSA/CSV

FDA Part Two – Data Integrity: The Challenges & CSA Application

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CSA Revolution Season Two Episode 2 with FDA
January 26, 2021
CSA/CSV

CSA Revolution Season Two Episode 2 with FDA

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CSA Revolution: Season Two, Episode I with Data Integrity
November 18, 2020
CSA/CSV

CSA Revolution: Season Two, Episode I with Data Integrity

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CSA Revolution Webinar Series Episode 5 w/ Boston Scientific
September 3, 2020
CSA/CSV

CSA Revolution Webinar Series Episode 5 w/ Boston Scientific

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CSA Revolution Webinar Series Episode 6 w/ Lantheus & FDA
September 17, 2020
CSA/CSV

CSA Revolution Webinar Series Episode 6 w/ Lantheus & FDA

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CSA Revolution Webinar Series Episode 4 w/ MedTronic
August 20, 2020 03: 00 PM ET
CSA/CSV

CSA Revolution Webinar Series Episode 4 w/ MedTronic

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CSA Revolution Webinar Series Episode 3 w/ Fresenius, FDA
August 6, 2020
CSA/CSV

CSA Revolution Webinar Series Episode 3 w/ Fresenius, FDA

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CSA Revolution Webinar Series Episode 2 w/ Johnson & Johnson
July 23, 2020 03: 00 PM ET
CSA/CSV

CSA Revolution Webinar Series Episode 2 w/ Johnson & Johnson

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CSA Revolution Webinar Series Kickoff w/ the FDA
July 16, 2020 03: 00 PM ET
CSA/CSV

CSA Revolution Webinar Series Kickoff w/ the FDA

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CSA Revolution Webinar Series Episode 1 w/ Gilead Life Sciences
July 9, 2020
CSA/CSV

CSA Revolution Webinar Series Episode 1 w/ Gilead Life Sciences

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Everything about FDA’s draft guidance on CSA
March 11, 2020 ET
CSA/CSV

Everything about FDA’s draft guidance on CSA

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Panel discussion on “The Future of Quality Management and FDA Case for Quality initiatives”
February 27, 2020
eQMS

Panel discussion on “The Future of Quality Management and FDA Case for Quality initiatives”

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What is changing at FDA in terms of Quality vs Compliance?
February 18, 2020
eQMS

What is changing at FDA in terms of Quality vs Compliance?

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Q & A session with the FDA on FDA’s draft guidance Computer Software Assurance (CSA)
February 13, 2020 05: 59 PM ET
CSA/CSV

Q & A session with the FDA on FDA’s draft guidance Computer Software Assurance (CSA)

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Blog

AI-Generated Is Not AI-Approved: What the FDA’s April 2026 Warning Letter Means for Every GxP Team
Uncategorized

AI-Generated Is Not AI-Approved: What the FDA’s April 2026 Warning Letter Means for Every GxP Team

READ POST
Understanding CQV: Commissioning, Qualification, and Validation Explained
Validation

Understanding CQV: Commissioning, Qualification, and Validation Explained

READ POST
Top 10 QMSR Gaps Found During FDA Readiness Assessments and How a Checklist Helps
QMSR

Top 10 QMSR Gaps Found During FDA Readiness Assessments and How a Checklist Helps

READ POST
QMSR Explained: How FDA’s New Rule is Impacting Software Validation in MedTech
QMSR

QMSR Explained: How FDA’s New Rule is Impacting Software Validation in MedTech

READ POST
Driving Successful Organizational Change: The Role of Adoption in Achieving Long-Term Sustainability
OCM

Driving Successful Organizational Change: The Role of Adoption in Achieving Long-Term Sustainability

READ POST
Navigating Change Control with Veeva QMS: A Strategic Approach
Veeva

Navigating Change Control with Veeva QMS: A Strategic Approach

READ POST
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Events

May 7, 2026 | 5:30 pm to 8:00 pm
Burlington, MA

Annex 11 Revision, CSA, and the New Testing of GxP Systems GPG: An Author Panel Perspective

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Annex 11 Revision, CSA, and the New Testing of GxP Systems GPG: An Author Panel Perspective
Annex 11 Revision, CSA, and the New Testing of GxP Systems GPG: An Author Panel Perspective
May 7, 2026 | 5:30 pm to 8:00 pm
Burlington, MA

Annex 11 Revision, CSA, and the New Testing of GxP Systems GPG: An Author Panel Perspective

VEEVA MEDTECH SUMMIT 2026
May 11, 2026 - May 13, 2026
Chicago

VEEVA MEDTECH SUMMIT 2026

KENX- HARNESS THE POWER OF AI IN GXP- 2026
May 12, 2026 - May 13, 2026
San Diego, CA

KENX- HARNESS THE POWER OF AI IN GXP- 2026

ASQ World Conference on Quality & Improvement (WCQI) 2026
May 17, 2026 - May 20, 2026
Orlando, Florida, USA

ASQ World Conference on Quality & Improvement (WCQI) 2026

Siemens Realize LIVE Americas 2026
June 1, 2026 – June 4, 2026
Detroit, Michigan

Siemens Realize LIVE Americas 2026

Compliance Group at the 2026 ISPE AI in Life Sciences Summit
June 22, 2026 - June 23, 2026
Boston & Virtual

Compliance Group at the 2026 ISPE AI in Life Sciences Summit

KENX Validation University and Pharmaceutical Engineering Summit 2026
March 19, 2026- March 20, 2026
Philadelphia, PA

KENX Validation University and Pharmaceutical Engineering Summit 2026

ISPE-CaSA 33rd Annual Technology Life Sciences Show
February 25, 2026 , 7:00 AM to 8:00 PM EST
Raleigh, NC

ISPE-CaSA 33rd Annual Technology Life Sciences Show

KENX CSA & CSV University
December 9, 2025 - December 10, 2025
Philadelphia, PA

KENX CSA & CSV University

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White Papers

Uncategorized

AI-Generated Is Not AI-Approved: What the FDA’s April 2026 Warning Letter Means for Every GxP Team

Download
Validation

Understanding CQV: Commissioning, Qualification, and Validation Explained

Download
QMSR

Top 10 QMSR Gaps Found During FDA Readiness Assessments and How a Checklist Helps

Download
QMSR

QMSR Explained: How FDA’s New Rule is Impacting Software Validation in MedTech

Download
OCM

Driving Successful Organizational Change: The Role of Adoption in Achieving Long-Term Sustainability

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Veeva

Navigating Change Control with Veeva QMS: A Strategic Approach

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