Data Integrity Compliance for Computer Systems Regulated by FDA




Course Description:

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.

Join this session by expert speaker Carolyn Troiano, where she will discuss how to govern data, using 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, and when, under what circumstances, and, finally, using what methods.

Why Should You Attend?

After attending this webinar, you will understand the latest guidance and clarification issued by FDA on maintaining data integrity throughout the data life cycle. This is a quality control discipline necessary for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational data that is used to produce information leading to key decisions about products and regulatory matters.

Course Objectives:

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

  • Tie data integrity management 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 to ensure data integrity is maintained throughout its life cycle
  • Understand the role of data owners vs. data stewards in establishing and maintaining data integrity
  • Understand the criticality of data identity, trust, security, integrity, accessibility, reliability and consistency
  • Design a framework that encompasses people, processes and technology to ensure that all data is established and maintained in a state of integrity and in compliance with FDA requirements
  • Understand the policies and procedures necessary to support the maintenance of data integrity within a structured framework
  • Learn about the important concepts related to creating, maintaining and managing data integrity through good data governance practices
  • Learn how to document Computer System Validation (CSV) efforts to meet FDA compliance
  • Learn the most common pitfalls and challenges encountered when preparing documentation for FDA review
  • Learn about the best practices for documenting CSV efforts in alignment with the System Development Life Cycle (SDLC) methodology and FDA compliance
  • Learn about 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures and what you need to do to remain compliant
    • Learn about FDA compliance and enforcement trends

Who Will Benefit:

This webinar is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Personnel in the following roles will benefit:

    • 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 labelling records and practices
    • Senior Leadership
    • Human Resource Directors, Managers & Representatives
    • Compensation Professionals
    • Operations Professionals
    • Managers & Supervisors
    • Employees

About the Instructor:

Carolyn Troiano is a FDA Compliance Consultant for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.

Her experience includes more than 34 years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

Her successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. She has weathered numerous layoffs, mergers and acquisitions, and demonstrated very strong leadership skills in helping staff get through difficult times.

Her role has often been that of a liaison between technical and business staff, translating business needs into people, process and technical solutions, and developing ROI and risk models used to support funding.

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