Data Integrity and Data Governance for Computer Systems Regulated by FDA

Course Description

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.

While these practices have been employed, companies are being forced to do more work with fewer resources, leading to errors noted in citations, particularly in Warning Letters in the past 10 years. This has resulted in consequences including heavy fines and operational shut-downs.

Both FDA and industry recognize the need to review current practices to ensure they meet the standards for creating data with integrity and maintaining it as such throughout the entire life cycle. 

In this CPE webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.

In this CPE webinar on information technology, we will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes the development of a company philosophy and approach and incorporating it into an overall computer system validation program and plans for individual systems that are regulated by FDA. It also requires a recognition that Data Integrity issues continue to be a strong area of focus by the FDA during an inspection, and there are many examples and best practices that will be covered in this webinar to address them.

Data governance will also be explored in terms of developing a framework for an organization. The key facets of the framework will be highlighted and examples provided to demonstrate the benefits of governing data effectively. When data is readily available and easy to access, users can make decisions more expeditiously and appropriately. The data structure must be considered to build consistency in the use of terminology and key phrases. This leads to improved search capability.

You’ll learn best industry practices for organizing a data governance program in this CPE course.

As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt. New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

Learning Objectives

• To discuss the meaning of data integrity and focus on the criteria necessary for FDA compliance.
• To get an overview of recent FDA compliance and enforcement trends that focus on data integrity issues identified during audit and inspection.
• To analyze how to establish a data governance framework and program for data that is collected, analyzed, stored, or reported using a computer system subject to FDA regulations.
• To inspect 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.
• To investigate 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.
• To analyze how to leverage industry best practices in developing an overall data governance framework and program.
• To discuss how to ensure your data integrity is met and maintained through its life cycle.

Recommended For

• This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand Data Integrity and Data Governance for Computer Systems Regulated by the FDA.
• This CPE course will help you to learn the best industry practices for organizing a data governance program.

Who Should Attend?

Webinar Qualifies For

• 1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
• 1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)
• 1.5 CE Credit for Certified Fiduciary & Investment Risk Specialist (CFIRS)
• 1.5 CE Credit for Certified Wealth Strategist (CWS)
• 1.5 General Credit for Accountant/Bookeeper
• 1.5 CPD Credit of Information Technology for Chartered Professional Accountant (CPA Canada)
• 1.5 CPE Credit of Information Technology for Certified Fraud Examiner (CFE)
• 1.5 CPE Credit for Certified Government Financial Manager (CGFM)
• 1.5 CPE Credit of Information Technology for Certified Internal Auditors (CIA)
• 1.5 CPE Credit of Data governance for Certified Management Accountants (CMA)
• 1.5 CRE Credit for Certified Corporate FP&A Professional (FPAC)
• 1.5 CPE Credit for Certified Information Systems Auditor (CISA)

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