Labas , Paul

Director, IT Compliance and CSV
IPS-Integrated Project Services, LLC

Fifteen years of life sciences compliance and quality assurance experience with specific emphasis on computerized systems compliance and validation, and electronic data integrity. Proficiency with FDA 21 CFR Parts 11, 210/211, 820, EU EMA Annex 11, ISPE GAMP 5, FDA GxP, FDA and EMA guidance, IEEE and ISO Standards, SDLC and VLC models, infrastructure qualification, FMEA, etc. Experience with high criticality efforts such as system validation and quality measures deployed to meet FDA Consent Decree obligations, systems in use by 100,000+ worldwide users, etc.