FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems
Learn to validate FDA-regulated computer systems with the SDLC and GAMP 5, set risk-based testing, and keep data integrity and validated state through retirement.
Speaker
Carolyn Troiano
Computer system validation consultant · 35+ years in computer system validation
Overview
FDA continues to focus heavily on data integrity during inspections, and validation of regulated computer systems has to show clearly that each system does what it is meant to do. This 60-minute webinar on FDA data integrity guidance for regulated computer systems explains how to get there.
FDA's computerized systems guidelines date to 1983, and apart from technology, little about validation has changed. You'll learn to write unique, testable functional requirements and test scripts, set the level of testing from a risk assessment of likelihood, severity and detectability of failure, and use GAMP 5 categorization to justify it in the validation plan.
The session also covers validation policies and procedures, training, disaster recovery and business continuity, change control, periodic review, and how new technologies can add oversight burden.
Why attend: The share of Form 483 citations and warning letters involving data integrity rose sharply over a ten-year period, making it a major inspection target. A well-documented, SDLC-based validation that keeps systems in a validated state from conception to retirement helps you withstand FDA scrutiny and protect your data. This session suits IT, QA/QC, clinical data, compliance, lab and automation staff, CSV and GMP training specialists, business stakeholders and life sciences consultants.
What’s covered
- Computer system validation (CSV)
- System Development Life Cycle (SDLC) methodology
- GxP: GMP, GLP and GCP
- Data integrity requirements and examples of FDA findings
- Validation strategy, planning and execution
- System risk assessment and determining the level of testing
- The GAMP 5 V model and software categorization
- 21 CFR Part 11 and FDA guidance on electronic records and electronic signatures
- Security, access, change control and audit trails
- Keeping data created and maintained with integrity through its life cycle
- Policies and procedures to support CSV and data integrity
- Training and organizational change management
- Disaster recovery, business continuity and periodic review
- Current FDA trends in compliance and enforcement
- Industry best practices and common pitfalls
- Q&A
Who should attend
What you get
About the speaker
Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
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