• Data Integrity and Data Governance for Computer Systems Regulated by FDA
  • Data Integrity and Data Governance for Computer Systems Regulated by FDA

    • Speaker : Carolyn Troiano
    • Session Code : CTSEP2623
    • Date : 26th September 2023
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 90 Mins


Navigating the FDA's guidelines on computer system validation is no simple task, particularly when you factor in the complexities of data integrity and governance. This webinar demystifies these intricate regulations, arming you with the knowledge you need to ensure your computer systems not only comply but excel in today's stringent regulatory environment.

We'll deep-dive into the FDA's current data integrity requirements and show you how to implement effective data governance policies. Learn the ins and outs of system validation—decoding its underlying risk assessment, the role of the GAMP 5 'V' Model, and the criteria necessary to guarantee data is handled with utmost integrity. We'll also discuss vital considerations for Disaster Recovery and Business Continuity Planning, as well as the impact of emerging technologies on compliance strategies. 

Beyond just theory, we'll provide actionable steps and best practices to maintain your systems in a validated state throughout their lifecycle. This includes concrete guidance on policy formulation, staff training, and how to adapt to regulatory changes without compromising data quality or system functionality. In short, this webinar is your comprehensive guide to staying ahead of the curve in a landscape where regulatory goalposts are constantly shifting.


Areas covered during the session:

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Data Integrity (DI)
  • Data Governance (DG)
  • Validation Strategy, Planning and Execution
  • System Risk Assessment
  • GAMP 5 “V” Model and Software Categorization
  • 21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
  • Security, Access, Change Control and Audit Trail
  • Criteria required to ensure data is created and maintained with integrity through its life cycle
  • Policies and Procedures to support CSV and DI assurance
  • Training and Organizational Change Management
  • Current FDA Trends in Compliance and Enforcement
  • Industry Best Practices and Common Pitfalls
  • Q&A

Why Should you attend?

ABCs of FDA Guidelines: Grappling with the nuances of FDA's guidelines for Computer System Validation (CSV)? This webinar is your roadmap, explaining these guidelines in a straightforward manner aligned with the System Development Life Cycle (SDLC) methodology.

Strategize Like a Pro: Develop and fine-tune your validation strategy with expert insights. Not only will you learn what it takes to validate a system effectively, but you'll also get tools to maintain that validation throughout the system's life cycle.

Stay Audit-Ready: Learn how to meticulously document your validation efforts to withstand FDA scrutiny. This webinar aims to make you audit-proof, ensuring the integrity of your data and processes.

In-Depth SDLC Framework: The webinar will walk you through the complete SDLC framework for validation planning, helping you understand every phase and requirement to keep your systems compliant.

Long-term Compliance: It’s not just about passing an audit; it’s about staying compliant. Understand the policies, procedures, and training needed to maintain your system in a validated state from inception to retirement.

Be Data Integrity-Savvy: In a world where data is the new oil, integrity is its refinery. With the increasing focus by the FDA on Data Integrity (DI), arm yourself with the latest requirements, examples of FDA findings, and best practices to keep your system compliant and risk-free.

Avoid Costly Mistakes: The penalties for non-compliance are not just regulatory but also financial and reputational. This webinar will provide you the wisdom to navigate the tricky landscape of FDA regulations, helping you avoid costly mistakes and reputational damage.

Get Ahead of the Curve: With ever-changing technology and regulatory landscapes, this webinar will give you the insights to adapt and thrive. It’s not just about what you face now, but also preparing for the challenges of tomorrow.


This isn't just another webinar; it's an investment in your professional future, arming you with the knowledge and strategies to navigate the intricate landscape of FDA-regulated computer systems. Whether you're a seasoned professional or new to the field, this webinar offers actionable insights you can apply immediately to ensure long-term compliance and data integrity. Don't miss out on this opportunity to elevate your understanding and skillset in an ever-evolving industry.

What industries will benefit from your training?

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:


  • Pharmaceutical (for drug products introduced using a medical device)
  • Medical Device
  • Biologicals (for biological products introduced using a medical device)
  • Tobacco (based on the Tobacco Control Act of 2009)
  • E-Liquid/Vapor (based on the “Deeming” Act of 2016)
  • E-Cigarette (based on the “Deeming” Act of 2016)
  • Cigar (based on the “Deeming” Act of 2016)
  • Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
  • Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who Should Attend?

  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors engaged in the internal inspection of labeling records and practices


Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, 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.

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

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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Tags: FDA, CSV, SDLC, Data Integrity, Data Governance, Compliance, Audit, Validation, Webinar, Carolyn, Troiano, September 2023, Webinar