Simone Ristori
Speaker
IT Infrastructure Qualification, CSV/CSA Advisor Engineer
Local Equity Partner
A +17 years long career in Information Technology and Computer Systems Validation in the Life Science industry. Degree in Electronic Engineering at the University of Florence, he worked as teacher of informatics for Pixel Association in Florence before joining PQE in 2003. He is currently Principal Consultant. Strong team player with good communication skills and ability to adapt and work in multi-cultural working environments. He led a huge number of IT Infrastructure Qualification projects for both domestic and international regulated customers. His specialties include also IT Assessments and Audits of IT suppliers. Areas of expertise are: Information Technology, IT Quality, Disaster Recovery.
Gaurav Walia
Speaker
Sr. Global Director of Business Development Principal Computer Systems Validation & DI Consultant
Over 24 years of experience in Pharma/MD and Consumer Healthcare environment with extensive experience in end to end processes such as CSV, 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.
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.
Benedetta Bartoli
Special Guest
ICT Quality Assurance and CSV Manager at MENARINI Group
Benedetta graduated in Mathematics at University of Florence and has 25 years of experience in ICT.
Since she joined Menarini, in 2003, she focused on ICT Compliance in regulated environments (Pharmaceutical and Medical device) following global validation and qualifications projects in Europe and US with growing responsibilities.
Filippo Del Re
Special Guest
ICT Specialist & Infrastructure Manager at MENARINI Group
10 years of experience in ICT with a focus on manufacturing, automation and laboratory system management
Previously consulting at PQE Group, he joined Menarini in 2022 where he now focuses on ICT OT solutions for manufacturing.
Rachele Bruscoli
Moderator
Business Development Manager
Proudly joined PQE in January 2021, which was my career kick-off in the Life Science industry, in the Digital Governance department as IT Technical Services Executive Assistant.
Led a 9-mate team for a relevant Digital Governance campaign hitting the regulated customers worldwide, which topics focused on: Information Technology, IT Quality, Cybersecurity, IT Audits, and Company to Company migration.
Since January 2022, I have been moving to the Business Intelligence Department.
Master's Degree in Economy and Management at the University of Florence (Italy) in 2018.