Critical Risk Assessment for Software Validation

-
Speaker : GAURAV WALIA
-
When : Wednesday, August 20, 2025
-
Time : 12 : 00 PM EST
-
Add To Calendar
Refer a Friend
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)
Revolutionizing CSV Embracing Critical Thinking, Risk Analysi,s and Cutting Edge Tools in an Evolving Tech Landscape
- Demonstration of Risk Assessments Concepts
- Demonstration of Risk Assessments Tools and Strategies
- Pivoting Away from Traditional Risk Assessments and Encompassing Critical Thinking
- Pivoting from CSV to CSA with Critical Thinking/Risk Assessment in Mind
- Real World Highlights of CSA Implementation Case Study with Critical Thinking and Modernized Risk Assessment
Takeaway Tools
- FDA CSA Draft Guidance (Sep 2022)
- Article link on Critical Thinking with Modernized Risk Assessment and QdB.
- Case Study Example with Critical Thinking and Modernized Risk Assessment
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 Critical Risk Assessments in Software Validation.
In addition, if you want to learn about examples of how to perform augmented Risk Assessments, then please attend.
You will learn by attending the main parameters on how to perform a Proper Risk Assessment.
Don’t miss out to stay up to date on our Industry Trends.
Topic Background
Demonstrating the Main concepts of how to perform Critical Risk Assessments in Software Validation.
-
$199.00
-
