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Data Integrity and Data Governance for Computer Systems Regulated by FDA

  • Accountant
  • CFE
  • CGFM
  • CISA
  • CPA/CITP
  • CIA
  • CMA
  • CPA (US)
  • CRISC
  • FPAC

Published: March, 2022

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Before starting this self study program, please go through the instructional document.

  • Course Description
  • Course Qualification
  • Presenter
  • FAQ

Course Description

Overview

  • GxP system
    2 mins
  • What is Data integrity
    8 mins
  • FDA's new guidance on data integrity
    16 mins
  • FDA inspection trends and data integrity
    34 mins
  • Computer system validation (CSV)
    49 mins
  • Data governance framework
    66 mins

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?

  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
  • 1.5 CPE Credit of Information Technology and Security for Certified in Risk and Information System Control (CRISC)
  • 1.5 General Credit of Information Technology for Accountant/Bookkeeper/Tax Professionals
  • 1.5 CPE Credit of Information Technology for Certified Fraud Examiner (CFE)
  • 1.5 CPE Credit of Information Technology 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 of Information Technology (inc. Excel) for Certified Corporate FP&A Professional (FPAC)
  • 1.5 CPE Credit of Data governance for Certified Information Systems Auditor (CISA)
  • 1.5 CPD Credit of Information Technology for Certified Information Technology Professionals (CITP)

Additional details

  • Course Level :
    Basic
  • Credits :
    1.5
  • Instructional Method :
    QAS Self Study
  • Pre-requisites :
    None
  • Advance Preparation :
    None

NASBA APPROVED

MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478

MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.

Presenter

About Presenter

Carolyn Troiano

Account Executive, BrainStorm Central Consulting LLC

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.

About Company

BrainStorm Central Consulting LLC

BrainStorm Central Consulting is the leader and premier catalyst for moving companies to a new level by outstripping conventional wisdom and thought, and creating a strategy that goes beyond the realm of “better, faster, cheaper”.


"Our experience will lead you to us, your experience will keep you coming back..."


FDA Compliance Training Topics Offered:

• Developing a Strategic Approach to FDA Compliance for Computer Systems

• FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

• Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

• Medical Device Industry Trends for Computer Systems Regulated by FDA

• Tobacco and Related Industry Trends for Computer Systems Regulated by FDA

• FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars

• FDA Compliance and Mobile Applications

• Good Documentation Practices to Support FDA Computer System Validation

• In-Depth Computer System Testing of Computer Systems Regulated by FDA

• Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

• Data Integrity and Governance for Computer Systems Regulated by FDA

• Trends in FDA Compliance and Enforcement for Regulated Systems

• Best Practices in Preparation for an FDA Computer System Audit

• Functional System Requirements for Computer Systems Regulated by FDA

• Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

• 21 CFR Part 11 (e-Records/Signatures) Compliance for Computer Systems Regulated by FDA

• C-TPAT Compliance for FDA-Regulated Industries

• Medical Device Cybersecurity and FDA Compliance

• 21st Century Cures Act and Medical Device Software Compliance

• Medical Device Software 62304 Compliance

• Creating, Reviewing & Managing Audit Trails: Compliance for FDA-Regulated Computer Systems

• Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

Faq

FAQs content

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Ratings and Review

4.6

8 Ratings

Excellent

5

Very Good

3

Average

0

Poor

0

Terrible

0

MO

Mo Omar, Accountant, CPA (US)

May 9th, 2022

All is good. The only thing I'd like is if you have more classes later in the day. Your schedule is very early for us in Arizona. I can't attend most of them.

JS

John Sharp, CPA (US)

May 10th, 2022

Very informative about data

Data Integrity and Data Governance for Computer Systems Regulated by FDA

PREMIUM

1.5 Credits

Subject Area

Information Technology