Project Management Best Practices for Computer Systems Regulated by FDA
Apply project management best practices to FDA-regulated computer system implementations — covering SDLC, CSV, GAMP V, roles, documentation, and maintaining systems in a validated state.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
What You'll Learn
About the event
About this event
This course discusses the importance of applying industry best practices when managing projects involving development, configuration, implementation, testing, validation, and other System Development Life Cycle (SDLC) phases for any IT system used in an FDA-regulated environment.
Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. This course describes the best practices for managing such a project — including who should be responsible for tasks, how the documentation should be accomplished, and what specific criteria define success.
Code: FDB2046
Curriculum
Requirements
- IT analysts, developers, QC/QA managers, clinical data managers, and lab managers
- Applicable to compliance auditors, automation analysts, CSV specialists, and consultants in regulated industries
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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