GAURAV WALIA

Mr. Walia is currently the VP of CSV/CSA/DI, and Digital Governance, Head of PQE Chicago Office, and Sr. Associate Partner at PQE Group, 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)