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Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity. Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.
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Understand what FDA’s inspection shift means for your audit readiness plan
FDA inspections are becoming more risk-based, systems-focused, and data-driven, creating new pressure on quality systems, digital records, risk management, and inspection response teams. In this webinar, Veranex quality and regulatory experts will break down how FDA’s updated inspection approach is shaping expectations across medical device and combination product manufacturers. Attendees will learn where readiness gaps commonly appear, how to prepare for remote, hybrid, and on-site inspections, and how to strengthen inspection readiness before compliance risk becomes a finding.
Paige Sutton-Smith is a Quality Management and Regulatory professional with 12 years track record in the medical device industry. Her expertise includes US regulatory approval, product design and development, process validations, V&V, complaint handling, QC strategies, QMS deployment, and auditing to FDA 21 CFR 820 / ISO 13485. She is experienced in maintaining QMS certification and FDA approvals for invasive and implantable products. Paige holds a BSc in Material Science and Engineering from Lehigh University (PA), achieved a RAC-Devices certification, is a Lean Six Sigma Black Belt, and ASQ certified as a Certified Quality Engineer.
Learning Objectives
Evaluate
Assess your current quality systems and inspection readiness against FDA’s evolving expectations, including data integrity, digital records, risk management, and post-market processes.
Apply
Use practical strategies to prepare for remote, hybrid, and on-site inspections, from documentation readiness to front-room and back-room response planning.
Recognize
Identify common compliance pitfalls tied to the revised inspection approach and understand how to reduce avoidable findings before they become regulatory risk.
Learn More from Our Specialists Who Work Inside Medtech Complexity Every Day
Veranex helps you navigate changes with confidence by providing comprehensive consultation, execution support, and quality system planning.
