The Next Era of FDA Inspections: Digital, Data-Driven, and QMSR-Ready
Prepare for the future of FDA Inspections with practical guidance on QMSR, risk-based inspection techniques, FDA AI initiatives, and inspection readiness.
Training Overview
The FDA inspection landscape is evolving rapidly. With the implementation of the Quality Management System Regulation (QMSR), increasing use of risk-based inspection techniques, and emerging AI-enabled tools, medical device manufacturers must be prepared for a new era of regulatory oversight. In this live, instructor-led training, you'll gain practical insights into FDA's evolving inspection approach, understand what these changes mean for your organization, and learn proven strategies to strengthen inspection readiness and compliance.
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Date: August 20, 2026
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Time: 9AM – 12PM EST (3PM – 6PM CET)
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Format: Virtual
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Duration: 3 hours
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Instructor: Paige Sutton-Smith, Sr. Manager, Quality & Regulatory Affairs
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Price: 345 EUR / $400 USD
Paige Sutton-Smith
Sr. Manager, Regulatory Affairs & Quality Assurance
Paige Sutton-Smith is Senior Quality & Regulatory Affairs Manager at Veranex with nearly 15 years in the medical device industry. Paige has a wide range of experience including US and EU regulatory strategy and approval, FDA and Notified Body interactions, product design and development, process validations, risk management, complaint handling, QMS deployment, and many others. Her track record includes numerous FDA approvals for active, invasive, and implantable products in areas such as organ preservation, orthopedics, insulin delivery, implantable neurostimulators, and cardiovascular implants. Paige holds a BSc in Materials Science and Engineering from Lehigh University, has achieved a RAC-Devices certification, and is a certified auditor, Lean Six Sigma Black Belt, and ASQ Certified Quality Engineer.
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Training Objectives
Participants will learn how to:
- Explain the key components and intent of FDA’s new inspection technique (including risk-based and system-focused approaches), including FDA’s use of their AI tool, Elsa.
- Understand the requirements and impact of the Quality Management System Regulation (QMSR) and its alignment with ISO 13485.
- Apply inspection readiness best practices aligned with evolving FDA expectations and digital tool usage.
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Training Content
1. FDA’s New Inspection Technique
- Evolution of inspection models (QSIT → risk-based/data-driven inspections)
- Use of advanced analytics by FDA investigators, include Elsa
- Inspection focus areas under modernization initiatives
- Implications for manufacturers and audit readiness
2. Quality Management System Regulation (QMSR)
- Overview of QMSR final rule and implementation timeline
- Alignment with ISO 13485: key similarities and differences
- Transition considerations from legacy 21 CFR Part 820
- Impact on procedures, records, and audits
3. Inspection Readiness & Case Studies
- Common FDA observations related to data integrity and documentation
- Scenarios involving AI-assisted work products
- Mock inspection exercise incorporating ELSA usage
- Group discussion: identifying compliance gaps
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Training Format
- Instructor-led presentation (virtual)
- Guided hands-on exercises (e.g., prompt writing, reviewing AI outputs)
- Case study discussions and mock inspection scenarios
- Knowledge check (quiz and/or facilitated discussion)
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Prerequisite
- Basic understanding of FDA regulations and quality systems
- Familiarity with 21 CFR Part 820 (legacy QSR) is preferred
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Target Audience
- Quality Assurance and Regulatory Affairs professionals
- Compliance, audit, and inspection readiness teams
- Manufacturing and operations leadership
- R&D and product development teams
- Document control and quality systems personnel
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Price
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345 EUR / $400 USD
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Learn from Specialists Who Work Inside Medtech Complexity Every Day
Talk with Veranex about upcoming training dates, private sessions, or tailored programs built around your organization’s device, IVD, regulatory, clinical, or quality needs.