Webinar on Data Governance for Computer Systems Regulated by FDA

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 Will Benefit:

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.