Computer Software Assurance (CSA) Implementation with Focus on Industry Case Study
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Speaker : GAURAV WALIA
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When : Friday, July 11, 2025
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Time : 01 : 00 PM EST
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Mr. Walia is currently the VP of CSV/CSA/DI, and
Digital Governance, Head of PQE Chicago Office, and Sr. Associate
Partner at PQE Grou.p
Also, he is an Adjunct Lecturer at Temple University, School of Pharmacy, RA/QA Graduate Program.
With
over 28 years of experience in Pharmaceutical/Medical Device and
Consumer Healthcare environment with extensive experience in end to end
processes such as Computerized Systems Validation, Computer Software
Assurance, Data Integrity, Cleaning Validation QMS, SDLC, Agile and
Waterfall Methodologies, Validation and Qualification (within, IT,
Laboratory, Manufacturing for Standalone through Enterprise Systems), IT
Policies and SOP generation, review, revision and approval, IT
Infrastructure Review and Qualification/Validation and
Audit/Documentation, overall Audit/Assessment Execution with GAP
Generation and Remediation, Customer and Vendor Audit and Compliance
Quality Assurance Compliance and Laboratory Analyses. He also recently
has been involved in the areas of Cybersecurity, Machine Learning and
AI.
Mr. Walia has over 100 FDA Audits/Inspections under his belt as well as 3 Major Consent Decree Projects focusing on Computer Systems Validation and Data Integrity, and is also a former Director of R&D, Quality, and IT CSV.
Mr.
Walia is a Member of PDA and ISPE as well as a contributing expert with
publications for KENX, Executive Advisory Board Member for IVT/Informa,
and current Vice Chairman in Chicago for the American Society for
Quality (ASQ)
Computer Systems Validation (CSV) and Computer Software Assurance are both crucial aspects in ensuring compliance, reliability, and security in an FDA-regulated environment, but they differ in focus and execution.
- Objective: Understanding the distinctions between Computer Systems Validation (CSV) and Computer Software Assurance in FDA-regulated settings.
- Importance: Highlighting their roles in ensuring regulatory compliance and software reliability.
- Definition: Explain CSV as the process of ensuring that a computerized system satisfies predefined requirements and is compliant with regulations.
- Focus: Emphasize validation of the entire system, including hardware, software, processes, and documentation.
- FDA Compliance: Showcase how CSV aligns with FDA regulations (e.g., 21 CFR Part 11).
- Definition: Define Software Assurance as the process of guaranteeing software reliability, security, and compliance with established standards.
- Focus: Highlight the emphasis on the software aspect, encompassing validation, security, and ongoing monitoring.
- FDA Compliance: Illustrate how Software Assurance addresses FDA guidelines concerning software-specific regulations.
- CSV Objectives: Focus on system-wide validation, ensuring complete compliance of the entire computerized system.
- Software Assurance Objectives: Concentrate on assuring the reliability, security, and compliance of the software specifically.
- CSV Methodologies: Discuss methodologies involving complete system validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Software Assurance Processes: Highlight processes like code reviews, vulnerability assessments, and continuous monitoring focused on software integrity
Areas Covered
CSV, CSA, FDA draft Guidance
Who Should Attend
Sr. Manager, Director, VPs, Validation, Quality, IT
Why Should You Attend
People should attend that want to know the latest trends in Computer Software Assurance. In addition, if you want learn about about FDA’s CSA Draft Guidance then please join.
You will learn by attending the difference between CSV and CSA as ell as Real Life Case Study Example of this being Implement.
Don’t miss our to stay up to date on our Industry Trends.
Topic Background
Demonstrating the Difference in CSV vs. CSA and with Real Life Case Study and analysis of FDA Draft Guidance.
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$199.00
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