CSV To CSA Transition Webinar: 21 CFR Part 11, Data Integrity, Data Privacy, & Use Of AI In FDA-Regulated Systems (LIVE & ON-DEMAND: June 16Th - June 17Th, 2026)

2026-04-15 06:17:09

(MENAFN- GlobeNewsWire - Nasdaq) Explore opportunities by adopting CSA principles beyond their intended focus, ensuring alignment with Part 11, data integrity, and QMS. Learn transition from CSV to CSA with detailed steps and address potential issues. Access supplementary materials and Q&A to reinforce seminar learning.

Dublin, April 15, 2026 (GLOBE NEWSWIRE) -- The "CSV to CSA Transition: 21 CFR Part 11, Data Integrity, Data Privacy, & Use of AI in FDA-Regulated Systems (June 16th - June 17th, 2026)" training has been added to ResearchAndMarkets's offering.

The seminar will include a Q&A session at the end of each day. There are Appendices at the end of the slide deck that provides references related to the content that can be reviewed at your leisure. There is also a series of questions with answers provided, along with a rationale for the correct choice. Again, this can be reviewed after the event to further support the learnings from this seminar.

We can begin using some of the CSA principles today, even outside of the intended focus for the final guidance. This is provided that for these other areas, we are able to adequately explain their use and defend the tie-in to Part 11, data integrity, the Quality Management System (QMS) and other relevant documents and programs.
In this seminar, we'll provide an overview of the transition process in going from CSV to CSA. We'll then dive into a step-by-step guide for the transition that can be done by any company. The transition steps, related documents and other artifacts, and the potential issues to watch out for will be laid out very carefully.
Who Should Attend:

Information Technology Analysts
Information Technology Developers and Testers
Software Quality Assurance Professionals
QC/QA Managers and Analysts
Analytical Chemists
Compliance and Audit Managers
Laboratory Managers
Automation Analysts
Manufacturing Specialists and Managers
Supply Chain Specialists and Managers
Regulatory Affairs Specialists
Regulatory Submissions Specialists
Risk Management Professionals
Clinical Data Analysts
Clinical Data Managers
Clinical Trial Sponsors
Computer System Validation Specialists
GMP Training Specialists

Agenda
Day 01
Morning Session:

Computer System Validation (CSV)
GAMP5 "V" Model
System Development Life Cycle (SDLC) methodology
Validation Planning
15-Minute Break
Validation Requirements
Validation Testing
Validation Reporting
Requirements Traceability Matrix (RTM)
1-Hour Lunch Break

Afternoon Session:

Computer Software Assurance (CSA)
Critical Thinking
GAMP5, 2nd Edition and its alignment with CSA
Transition from CSV to CSA
15-Minute Break
21 CFR Part 11 Guidance (ER/ES)
21 CFR Part 11 Requirements and Controls
Common 21 CFR Part 11 Deficiencies
15-Minute Q&A

Day 02
Morning Session:

Data Integrity Guidance (ALCOA+++ Principles)
Data Integrity Requirements and Controls
Common Data Integrity Deficiencies
Data Life Cycle Management
Data Governance
15-Minute Break
Data Privacy
Commercial-Off-the-Shelf (COTS) solutions
Cloud Services
Software-as-a-Service (SaaS) Solutions
Platform-as-a-Service (PaaS) Solutions
Infrastructure-as-a-Service (IaaS) Solutions
Single-Sign-On (SSO)
Vendor Audit
1-Hour Lunch Break

Afternoon Session:

Artificial Intelligence (AI)
Machine Learning (ML)
Large Language Models (LLMs), including ChatGPT
Retrieval-Augmented Generation (RAG)
Recursive Language Models (RLMs)
15-Minute Break
FDA Regulatory Compliance
Current FDA Regulatory Enforcement Trends
FDA Inspection Types
Internal Audit
Industry Best Practices
15-Minute Q&A

For more information about this training visit

About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

CONTACT: CONTACT: Laura Wood,Senior Press Manager... For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

MENAFN15042026004107003653ID1110985285

Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.