How much does Cybersecurity Expectations for GxP Systems cost?

Registration options: Recording – 1 Viewer: $450; Recording – Unlimited Viewers: $1500.

Do I receive a certificate after completing Cybersecurity Expectations for GxP Systems?

Yes, a certificate of completion is included with your registration.

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Recorded WebinarNew

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.

4.8(0 reviews)

1.5 hours

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

Cybersecurity Expectations for GxP Systems

Quantity

Recording – 1 Viewer

$450.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

Identifying GxP systems that require cybersecurity controls

FDA expectations for security in CSA/CSV environments

SDLC and GAMP 5 (Second Edition) security touchpoints

Data integrity and Part 11 risks linked to cybersecurity

Access control, audit trails, and role management

Cloud/SaaS cybersecurity responsibilities and supplier evidence assessment

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

Identifying GxP Systems That Require Cybersecurity Controls

12 min

FDA Expectations for Security in CSA/CSV Environments

12 min

SDLC and GAMP 5 Security Touchpoints

12 min

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.

45+ Years CSV Experience21 CFR Part 11 Co-DeveloperIndependent FDA Consultant

Quantity

Recording – 1 Viewer

$450.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

Topics

Cybersecurity GxP FDA CSA CSV Cloud SaaS Data Integrity Part 11

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