Join us on an informative episode of BioTalk with Rich Bendis as we delve into the fascinating realm of computer systems validation (CSV) and its significant impact on quality assurance in the life sciences industry. Our guest, Mr. Gaurav Walia, Senior Global Director of Business Development at PQE Group and Principal SME of Computer Systems Validation, Computer Software Assurance, and Data Integrity and Sr. Associate Partner, brings extensive expertise in CSV and compliance consulting services.
Discover the essential role of CSV in ensuring the integrity, reliability, and compliance of computerized systems used in pharmaceutical and medical device manufacturing. Mr. Walia, a recognized authority in the field, will provide insights into CSV's challenges and best practices, emphasizing the critical importance of regulatory adherence and data integrity.
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Mr. Walia is currently Senior Global Director of Business Development and Principal SME of Computer Systems Validation and Data Integrity at PQE Group. With over 25 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. Possesses wide knowledge of US cGMP (21 CFR Part 210-211 and 820), GxP Guidelines, 21 CFR Part 11, EU Annex 11, ISO 9001 and ALCOA+ Data Integrity Principles, GAMP 5 and main FDA Guidance(s) for Industry. Autonomously and effectively perform the execution of a GxP and/or ALCOA+ Data Integrity Assessment by directing critical business relevant conversations with client leadership and internal stakeholders. Review and critique of client-produced validation documentation focusing on GxP requirements. Proven track record in enhancing staff performance, validation documentation technical writing and leading high-performing teams.
Mr. Walia has also been a leading Industry Speaker and Trainer in the Pharmaceutical and Medical Devices Arenas with focus on Cleaning Validation, OOS/OOT (Investigations, Root Cause Analysis and CAPA’s), QMS, Gap Assessments, Remote Inspections, Consent Decree, Remediation, CSV/CSA, Data Integrity, Digital Governance, Cybersecurity, Compounding Pharmacies, Agile Methodologies within Validation, etc. Mr. Walia also is a part of the IVT Executive Advisory Board, Chairperson for IVT’s Compounding Pharmacy and ISPE member serving on Women in Pharma and Pharma 4.0 / Laboratory Paperless Automation.
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 has trained senior FDA Inspectors in Computer Systems Validation and Data Integrity