Technical
In 2022, the US Food and Drug Administration (FDA) issued their draft guidance “Computer Software Assurance for Production and Quality System Software”
Gaurav Walia
PQE Group
Mr. Gaurav Walia’s Professional Summary
Over 24 years of experience in Pharmaceutical/Medical Device and Consumer Healthcare environment with extensive experience in end to end processes such as Computerized Systems Validation, Data Integrity, QMS, SDLC, Validation and Qualification, 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 13 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.
Develop and maintain accurate departmental resource models to facilitate resource allocation and availability, and to ensure feasibility of projects, from scoping stage through to completion. Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues. Solid competencies in leadership, conflict resolution, oral and written communications, acumen and persuasion as well as organizational savvy.
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 currently as Senior Global Director of Business Development and Principle SME of Computer Systems Validation and Data Integrity at PQE Group (Pharmaceutical Quality Europe).
Over 24 years of experience in Pharmaceutical/Medical Device and Consumer Healthcare environment with extensive experience in end to end processes such as Computerized Systems Validation, Data Integrity, QMS, SDLC, Validation and Qualification, 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 13 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.
Develop and maintain accurate departmental resource models to facilitate resource allocation and availability, and to ensure feasibility of projects, from scoping stage through to completion. Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues. Solid competencies in leadership, conflict resolution, oral and written communications, acumen and persuasion as well as organizational savvy.
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 currently as Senior Global Director of Business Development and Principle SME of Computer Systems Validation and Data Integrity at PQE Group (Pharmaceutical Quality Europe).
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