FDA scrutiny of medical device software continues to intensify. Organizations that treat validation as a documentation exercise rather than a risk-based control strategy face serious regulatory exposure.

This webinar challenges professionals to evaluate whether their software validation approach would withstand a real FDA inspection. Participants will explore regulatory requirements under 21 CFR Part 820, relevant FDA guidance documents, and risk-based validation principles that align with Quality System expectations.

Attendees will review common inspection findings, validation documentation weaknesses, and gaps between theory and implementation. The session emphasizes building defensible validation protocols, traceability, test evidence, and lifecycle controls that demonstrate compliance—not just claim it.

This program is designed to help organizations move beyond checkbox validation and toward sustainable, inspection-ready software quality systems.

After this webinar attendees will be able to answer:

• Are our software validation processes aligned with current FDA expectations?
• What documentation gaps could expose us during an FDA inspection?
• How do we demonstrate objective evidence that software performs as intended?
• What are the most common validation deficiencies cited in warning letters?
• Are we validating based on risk—or simply following templates?

This webinar benefits the following agencies:

• Medical device manufacturers
• Quality assurance and regulatory affairs departments
• Software development and validation teams
• Compliance and audit teams
• Engineering and product development groups
• Organizations preparing for FDA inspections

Who should attend?

• Regulatory Affairs Professionals
• Quality Assurance Managers and Directors
• Software Validation Engineers
• Design and Development Engineers
• Compliance Officers and Internal Auditors
• Executives responsible for FDA inspection readiness