Best Practices and Potential Pitfalls for Validating Computer Systems Regulated by FDA

Carolyn Troiano

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It's always challenging to optimize the approach to validating an FDA-regulated system and maintaining it in a state of compliance throughout its life cycle. The initial validation process can be streamlined by adequately planning all aspects of the effort. There are specific practices that can ensure the system is thoroughly and adequately designed, developed, implemented, tested and ready for production while avoiding the many potential pitfalls often encountered during the process. There are many examples of both the best practices and potential pitfalls that will be shared to ready you for your journey in FDA compliance.

In this webinar, you will learn how to do your due diligence in computer system validation by applying industry best practices and avoiding the potential pitfalls encountered by many. You will also learn how to manage these over the longer-term maintenance of a system, ensuring compliance with FDA throughout the system's entire life cycle.

Course Objective

  • Learn how to reduce the time and labor involved in a computer system validation effort by adequately planning your project.
  • Learn how to leverage past validation efforts to optimize results.
  • Learn how to ensure your team members are adequately trained to implement and maintain an FDA-regulated computer system in order to manage a successful outcome.
  • Learn how efficient and effective testing can ensure that all deficiencies are captured before a system is put into production, allowing for a smooth go-live without delay.
  • Learn how to keep on top of changes to the system over time to ensure it is maintained in a validated state and does not require a complete revalidation due to neglect.
  • Learn how to manage organizational change at the outset of a new system implementation project in order to avoid sabotage and other attempts to resist new ways of conducting business.
  • Learn how to evaluate business processes to ensure that these are optimized as the system is being developed and/or configured to enable improvements in efficiency and effectiveness of operations that will save money in the longer run.
  • Learn how to document all validation work in order to ensure that revisits to the deliverables during subsequent system changes are efficient and do not require extra labor to dig through poorly documented information.
  • Learn about potential pitfalls to the validation process through real industry examples.
  • Learn how to avoid and/or mitigate potential pitfalls during the validation process.

Course Outline

Topics covered include:

  • GxP systems
  • Computer System Validation best practices and pitfalls
  • System Development Life Cycle management
  • GAMP 5 system categorization and risk assessment/management
  • Applying best practices in Project Management to your validation effort
  • Design and management of system testing
  • Understanding Organizational Change Management to ensure minimal resistance and maximum adoption of new processes and technologies
  • Good Documentation Practices
  • Best practices for periodic system review and re-validation
  • Managing your IT and user resources during validation and through the system's life cycle
  • Leveraging work done by the vendor to assist with optimizing validation results
  • Ensuring the right policies and procedures are in place to minimize any confusion about roles and responsibilities and optimize efficiency in maintaining your system

Target Audience

  • Information Technology Managers and Analysts
  • Medical Affairs Managers and Analysts
  • Clinical Data Managers and Analysts
  • Marketing Managers and Analysts
  • Compliance Managers and Analysts
  • Regulatory Affairs Managers and Analysts
  • GMP Training Specialists
  • Business Stakeholders responsible for product presentation and promotional content
  • Consultants working in the life sciences industry who are involved in product presentation and promotional content
  • This webinar will provide valuable assistance to all FDA-regulated industries, including Pharmaceuticals, Biologicals, Medical Device, Tobacco, Animal Health.
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Carolyn Troiano,

Carolyn Troiano has more than 30 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, providing very creative and interactive presentations. 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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