Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.
During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance.
To take this a step further, we are now looking at ways to ensure the data that resides on these systems is also managed in a compliant manner and one that will provide the best results for operations at the lowest cost.
Why should you Attend
- Tie 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
- Design data governance processes that encompass people, processes and technology
- Understand the policies and procedures necessary to support the data governance framework
The attendees will have a good grasp of how to leverage the best practices across all systems by creating a standardized program for data governance.
Areas Covered in the Session
- Define the meaning of data integrity and focusing on the criteria necessary for FDA compliance
- Provide an overview of recent FDA compliance and enforcement trends that focus on data integrity issues identified during audit and inspection
- Establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations
- How to use a data governance framework as a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data
- How to ensure that data governed by FDA adheres 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
- How to leverage industry best practices in developing an overall data governance framework and program
- How to ensure your data
Who Will Benefit
- Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for data quality and integrity
- Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment
Carolyn (McKillop) Troiano has more than 35 years of experience 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, developing and executing compliance strategies and programs.
Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
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.