Data Governance for Computer Systems Regulated by FDA
Learn to set up a data governance framework that keeps FDA-regulated data accurate and secure across its life cycle, aligned with CSV, SDLC and 21 CFR Part 11.
Speaker
Carolyn Troiano
Computer system validation consultant · 35+ years in computer system validation
Overview
For pharmaceutical, biologics, vaccine, tobacco, animal health, medical device and other FDA-regulated companies, managing computer system data compliantly is critical. Thirty years of best practice have made it possible to manage the systems themselves cost-effectively; the next step is to govern the data on them just as well.
This 60-minute data governance webinar treats governance as a quality discipline covering how information is assessed, managed, used, improved, monitored, maintained and protected. It is a system of decision rights and accountabilities that sets who can do what with which data, when, under what circumstances and by which methods.
You'll define data integrity and FDA criteria, review FDA enforcement trends, and build a governance framework aligned with computer system validation (CSV), the SDLC and 21 CFR Part 11.
Why attend: FDA audit and inspection findings show a high share of data integrity issues, making it a key focus area. Anyone handling data subject to FDA inspection, audit or review needs to keep that data trustworthy throughout its life cycle and avoid negative findings. This session suits IT, QA/QC, laboratory, manufacturing, supply chain, CSV, clinical data, regulatory affairs and GMP training staff, business stakeholders, testers and life sciences and tobacco consultants.
What’s covered
- What data integrity means and the criteria for FDA compliance
- FDA compliance and enforcement trends on data integrity in audits and inspections
- Establishing a data governance framework and program for data collected, analyzed, stored or reported on FDA-regulated systems
- Using the framework to classify, organize and communicate decisions and actions on enterprise data
- Aligning governed data with CSV, SDLC methodology and 21 CFR Part 11 electronic records and signatures
- Using industry best practices to develop the framework and program
- Capturing and storing data with integrity and keeping it that way throughout its life cycle
- 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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