Data Governance for Computer Systems Regulated by FDA
Learn how to validate FDA-regulated GxP computer systems with the SDLC and GAMP 5, keep them validated through retirement, and set up data governance that protects data integrity.
Speaker
Carolyn Troiano
Computer system validation consultant · 35+ years in computer system validation
Overview
FDA expects computer systems used in regulated work to be classified, risk-assessed, tested and validated so they do what they claim to do. This 90-minute data governance and computer system validation webinar explains those expectations in detail.
You'll walk through the SDLC approach to CSV, including its phases, sequencing, deliverables and documentation. You'll see how GAMP 5 classification and risk help set the right level of validation effort for in-house, configurable and custom systems, with best practices and pitfalls for laboratory systems.
The session also covers keeping systems validated, archival and retirement, setting up a data governance committee with a charter and clear roles, and applying project and change management throughout.
Why attend: Validating a GxP system can be expensive, so the effort must match the system's risk and use. Weak governance puts data integrity at risk. This session suits anyone who plans, runs, maintains or supports a GxP system in pharmaceutical, medical device, biotech or tobacco companies, including data owners and stewards, IT, QA/QC, validation, laboratory and compliance staff, and consultants.
What’s covered
- Data integrity and data governance
- FDA GxPs: GMPs, GLPs, GCPs and GDPs
- Computer system validation methodology
- The SDLC framework
- Risk management and GAMP 5
- Compliance strategy and cost vs compliance
- Industry best practices
- Policies and procedures
- Training
- Leveraging vendors
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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