Industry Insights

Webinars

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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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

Driving Successful Organizational Change: The Role of Adoption in Achieving Long-Term Sustainability
Navigating Change Control with Veeva QMS: A Strategic Approach
Keep The Change: Change Management plan and a communication plan
Making Change Meaningful: Perception Is Greater Than Reality
From Plans to Adoption – Compliance Group’s Approach to Effective OCM
Keep the Change: Navigating the Human Side of Transformation
View More

Events

March 19, 2026- March 20, 2026
Philadelphia, PA

KENX Validation University and Pharmaceutical Engineering Summit 2026

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KENX Validation University and Pharmaceutical Engineering Summit 2026
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

KENX MedTech Validation & Innovation University | GMP University
October 9 2025 – October 10, 2025
San Diego, CA

KENX MedTech Validation & Innovation University | GMP University

Veeva R&D and Quality Summit 2025
September 2, 2025 - September 4, 2025
Boston, MA

Veeva R&D and Quality Summit 2025

Harness the Power of AI in GxP
June 11 2025 – June 12 2025
Philadelphia, PA

Harness the Power of AI in GxP

Siemens Realize Live 2025
June 2nd 2025 - June 5th 2025
Huntington Place, Detroit

Siemens Realize Live 2025

Veeva MedTech Summit
April 28 2025 - April 30 2025
Austin, TX

Veeva MedTech Summit

KENX Validation University
March 26th 2025 - March 27th 2025
Philadelphia, PA

KENX Validation University

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White Papers

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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OCM

Keep The Change: Change Management plan and a communication plan

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OCM

Making Change Meaningful: Perception Is Greater Than Reality

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OCM

From Plans to Adoption – Compliance Group’s Approach to Effective OCM

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OCM

Keep the Change: Navigating the Human Side of Transformation

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