Computer Software Validation with Focus on FDA Regulations Including 21CFR Part 11
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Speaker : GAURAV WALIA
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When : Wednesday, June 18, 2025
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Time : 12 : 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) is crucial in ensuring compliance, reliability, and security in an FDA-regulated environment, but they differ in focus and execution.
- Objective: Understanding the distinctions within Computer Systems Validation (CSV) in FDA-regulated settings.
- Importance: Highlighting the 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 SoCSV 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 CSV 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).
CSV Processes: Highlight processes like code reviews, vulnerability assessments, and continuous monitoring focused on software integrity
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 to learn about FDA’s recent 483 and Warning Letter, then please attend.
You will learn by attending the main requirements and regulations of CSV and Regulatory findings.
Don’t miss out on staying up to date on our Industry Trends
Topic Background
Demonstrating the Main concepts of CSB ,including FDA regulations like Part 11
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$199.00
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