Gaurav Walia 

Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner, PQE Group

Mr. Walia is currently Senior Global Director of Business Development, Sr. Associate Partner and Principal SME of Computer Systems Validation, Computer Software Assurance and Data Integrity at PQE Group

With over 26 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.

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 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)

Mr. Walia has trained senior FDA Inspectors in Computer Systems Validation and Data Integrity