Data Integrity and Computer Systems Regulated by FDA

Live Webinar

  • 90 minutes

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many FDA-regulated organizations began seeking ways to move into a paperless environment. In this session, you will learn how to use a data and system governance framework as a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data.

Join this session by expert speaker Carolyn Troiano, where she will provide some insight into current trends in compliance and enforcement and cover the key aspects of complying with FDA requirements in both validating systems and maintaining them in a validated state throughout their entire life cycle.

Session Highlights:

  • Provide an overview of strategies for success in validating FDA-regulated computer systems, including 21 CFR Part 11 compliance, to ensure data integrity.

  • Provide an overview of strategies for success in maintaining FDA-regulated computer systems in compliance with FDA’s validation guidelines to ensure data integrity is maintained throughout its life cycle.

  • Provide a set of strategic and tactical best practices and industry standards to meet FDA compliance requirements for system and data governance throughout the life cycle of each.

  • 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

  • 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 maintained throughout its life

  • How to leverage industry best practices in developing an overall data governance framework and program to maintain data integrity throughout its life cycle.

Why You Should Attend:

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

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

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Carolyn  Troiano

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

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