Master The Vendor Auditing Of Your Computer Systems Regulated By FDA

  • Instructor : Carolyn Troiano
  • Level : Intermediate
  • Study time : 110 minutes
  • Course ID: TF3146
  • Included in Subscription Pack
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ABOUT THE COURSE

Are you confident your software vendors meet FDA compliance standards?
Do you know what to look for in vendor audits beyond checklists?
Could you prove your vendor’s Part 11 readiness during an FDA inspection?


This course walks you through the full vendor audit process—what to assess, how to ask the right questions, and how to document findings in a way that satisfies auditors and protects your systems.


WHAT WILL YOU GAIN
  • A structured process for auditing vendors of FDA-regulated computer systems
  • Insight into evaluating 21 CFR Part 11, security controls, support models, and compliance
  • Templates and tools to streamline documentation, tracking, and follow-up audits


WHY TAKE THIS COURSE
  • Vendor audit failures are among the top triggers for compliance findings
  • You’ll learn what to ask, where to probe, and how to evaluate answers
  • This is about more than paperwork—it's about protecting your operations


KEY AREAS COVERED
  • Developing a vendor audit strategy aligned with FDA expectations
  • Assessing compliance with 21 CFR Part 11 and security protocols
  • Evaluating vendor capabilities across code development and disaster recovery
  • Audit questions to uncover compliance gaps and technical weaknesses
  • Ongoing vendor monitoring through questionnaires and site visits
  • Leveraging vendor input for system validation, IQ/OQ, and Part 11 readiness

Quality training, expert insights, and answers that matter. Know your Expert

CAROLYN TROIANO

Carolyn Troiano brings over 30 years of experience in FDA-regulated computer system validation and compliance. A pioneer in 21 CFR Part 11 strategy and implementation, she’s guided top pharma and life science companies through major audits and system rollouts. Her training cuts through complexity—giving you exactly what you need to audit smart, stay compliant, and lead confidently.

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