Do I receive a certificate after completing Project Management Best Practices for Computer Systems Regulated by FDA?

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

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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.

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1.5 hours

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

Project Management Best Practices for Computer Systems Regulated by FDA

Quantity

Recording – 1 Viewer

$450.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

Project planning, execution, and management concepts for FDA-regulated systems

GxP Predicate Rules and Computer System Validation (CSV) fundamentals

System Development Life Cycle (SDLC) and risk-based approach to validation

GAMP V approach to system categorization and validation

Roles, responsibilities, training, and documentation required for FDA compliance

SOPs required for supporting a validated system and maintaining validated state

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

GxP Predicate Rules, CSV, and SDLC for Regulated Systems

15 min

Risk-Based Approach and GAMP V System Categorization

12 min

Implementation and Validation of FDA-Regulated Computer Systems

12 min

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.

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

Project Management FDA Computer Systems Validation SDLC GAMP GxP 21 CFR Part 11

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