Data Governance for Computer Systems Regulated by FDA

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.

• Tie data governance activities and investments to corporate drivers, strategy and compliance
• Set program objectives, decision-making structures, roles and responsibilities that fit your culture
• Explain the role of data owners vs. data stewards
• Understand why data identity, trust, security, integrity, accessibility, reliability and consistency matter
• Design governance processes that cover people, processes and technology
• Identify the policies and procedures that support the framework

• 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

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.

• Information Technology analysts
• Information Technology developers and testers
• QC/QA managers and analysts
• Analytical chemists
• Laboratory managers
• Automation analysts
• Manufacturing supervisors and other key personnel
• Warehouse and supply chain supervisors and other key personnel
• Computer System Validation (CSV) specialists
• GMP training specialists
• Business stakeholders/subject matter experts
• Business system/Application testers
• Clinical data managers and scientists
• Quality managers, chemists, and microbiologists
• Regulatory Affairs personnel
• Consultants in the life sciences and tobacco industries

Anyone who is involved in the development, testing, manufacturing, storage, handling, and distribution of products must understand and conform to FDA requirements for data quality and integrity. Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.

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.