Data Integrity and Governance for Computer Systems Regulated by FDA

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.

Learning Objectives:-

Upon completion of this session, attendees will have an understanding of how to:

• 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
• Q&A

Areas Covered:-

• Define the meaning of data integrity and focus 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 integrity is met and maintained through its life cycle
• Q&A

Background:-

After attending this webinar, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational information. It is a system of decision rights and accountabilities for information-related processes, executed according to agreed-upon models which describe who can take what actions with what information, when, under what circumstances, and, finally, using what methods.

Why Should You Attend:-

Upon completion of this session, attendees will have an understanding of how to effectively and efficiently manage data through a governance program that spans their organization. The attendees will also gain a thorough understanding of data integrity and the FDA’s concern with this area that is trending in terms of citations during the inspection. You will learn about how to assure data integrity requirements are met, including validation, testing, and other means of providing technical and/or procedural controls to mitigate any potential risk.

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. We will cover industry best practices and discuss ways to avoid the pitfalls of failing to secure and maintain data integrity.

Who Should Attend:-

• Information Technology Analysts
• Information Technology Developers and Testers
• Software Quality Assurance Professionals
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Vendors responsible for software development, testing, and maintenance

• Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance