Critical Risk Assessment for Software Validation
  • CODE : GAUR-0003
  • Duration : 60 Minutes
  • Level : Intermediate
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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)


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  • FDA CSA Draft Guidance (Sep 2022)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



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