Cybersecurity Expectations for GxP Systems
Translate FDA cybersecurity expectations into inspection-ready GxP actions — covering SDLC touchpoints, cloud/SaaS responsibilities, access control, and audit trail requirements.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
What You'll Learn
About the event
About this event
This course translates FDA cybersecurity expectations for GxP systems into clear, inspection-ready actions, bridging validation, data integrity, and modern IT realities. It equips teams to make defensible security decisions across cloud, SaaS, and device-connected environments without overengineering or missing critical FDA expectations.
Many organizations still treat cybersecurity as a pure IT concern rather than a regulated control impacting product quality, patient safety, and data integrity. Teams often struggle to align cybersecurity controls with CSA, CSV, and SDLC expectations. Gaps appear when security is bolted on after validation or responsibilities are assumed rather than verified.
This webinar provides practical clarity on how cybersecurity fits into regulated GxP systems, helping teams defend their approach when FDA asks how security supports compliance.
Code: MD1346
Curriculum
Requirements
- QA, Compliance, Regulatory Affairs, or IT professionals in FDA-regulated industries
- Applicable to medical device software engineers and digital transformation leaders
Meet Your Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures. During her career she has provided training on CSV, 21 CFR Part 11, Data Integrity, and many other compliance topics of interest to the life science industries.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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