Data Governance for Computer Systems Regulated by FDA

Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost, complexity and risk associated with maintaining it, and ensure that all FDA compliance requirements are met.

As decision making is a key area of interest in the regulated world, companies must be able to establish clear rules for managing source data used in critical regulatory decisions. Given the complexity of the data involved, and the compliance requirements mandated by FDA, organizations operating in this environment must have a formal system of governance.

Organizations continue to be more data-driven, meaning effective data governance is essential to providing trusted, timely, high-quality data consistently to all users. Creating a data governance initiative can be a daunting task, leaving companies feeling overwhelmed, but there are best practices that can get you started quickly down the road to success by providing a framework with the necessary depth, breadth and flexibility to overcome common pitfalls.

We will discuss the importance of establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations. A data governance framework is a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data. As data governed by FDA must adhere to the principles of Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, and Electronic Records and Signatures (21 CFR Part 11), as applicable, we will look at ways to leverage these in developing an overall data governance framework and program.

Areas Covered in the Session :

• Linking data governance activities and investments to corporate drivers, strategies and compliance
• Establish data governance program objectives, decision-making organizational structures and assigned roles and responsibilities that fit within the organizational culture
• Understand the role of data owners vs. data stewards
• Understand the criticality of data identity, trust, security, integrity, accessibility, reliability and consistency
• Designing data governance processes that encompass people, processes and technology
• Understand the policies and procedures necessary to support the data governance framework

Who Should Attend:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Course Director: CAROLYN TROIANO ‎

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.