• GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices
  • GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

    • Speaker : Carolyn Troiano
    • Session Code : CTAPR3024
    • Date : 30th April 2024
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 90 Mins



The landscape of computer system validation is undergoing a transformative shift with the introduction of GAMP®5, 2nd Edition, and the FDA’s draft guidance on Computer Software Assurance (CSA). This webinar aims to unpack these significant developments, elucidating their impact on the validation practices within the life sciences industry.


With technology advancing rapidly, the life sciences sector is moving towards more agile, efficient, and quality-focused methodologies. The webinar will explore how GAMP®5, 2nd Edition, aligns with the principles of CSA, advocating a risk-based and patient-centric approach over traditional, documentation-heavy methods. This alignment signifies a move towards leveraging technology to enhance quality and operational efficiency, without sacrificing compliance.


Attendees will gain insights into the agile and waterfall methodologies, understanding their pros and cons, and how they fit into the GAMP®5 “V” Model for successful system validation. The session will also cover the nuances of validating cloud-based solutions, including COTS, SaaS, IaaS, PaaS, and their regulatory considerations under 21 CFR Part 11 and data integrity guidelines.


Furthermore, the webinar will address the FDA’s current concerns and expectations, particularly focusing on the shift towards newer technologies that facilitate innovation without becoming a bottleneck due to regulatory constraints. The discussion will include how CSA’s risk-based approach, coupled with GAMP®5’s support for agile methodologies, offers a pathway to more efficient and effective validation processes.


By attending this session, participants will not only understand the regulatory shifts but also how to practically apply these changes in their validation strategies, ensuring that their systems are both compliant and aligned with industry best practices and FDA expectations.


Areas covered during the session:


  • Learn how to identify “GxP” Systems
  • Learn about FDA’s current thinking about technology and software development, and how this will impact industry
  • Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements and the Computer Software Assurance (CSA) approach, based on the draft guidance from FDA in September 2022
  • Learn about GAMP®5, Second Edition and how it aligns more closely with the CSA approach to validation
  • Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
  • Learn about cloud services and cloud service providers to optimize your experience
  • Learn ways to validate in the cloud without compromising quality or compliance
  • Learn the pros and cons of an agile vs. waterfall approach
  • We will discuss cloud computing, Computer Off-the-Shelf (COTS) software validation, and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectively
  • Discuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentation
  • Understand the best approach to Installation Qualification (IQ) testing when the system components are not on premise, but in the cloud
  • Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an Agile continuous validation approach
  • Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
  • Discuss the importance of “GxP” documentation that complies with FDA requirements
  • Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • Know the regulatory influences that lead to FDA’s current thinking at any given time
  • Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
  • Q&A


Why You Should Attend?


This webinar is a must-attend for professionals in the life sciences industry who are navigating the evolving validation requirements set by the FDA. You will gain a thorough understanding of how GAMP®5, 2nd Edition, and the FDA’s CSA draft guidance intersect and the strategic considerations this alignment necessitates for your validation processes.

Participants will learn about the transition from traditional CSV approaches to the more flexible and efficient CSA model, which prioritizes risk management and quality. The session will cover the practical aspects of implementing agile methodologies and automated testing within the validation framework, highlighting how these approaches can be integrated into your existing systems to enhance compliance and operational efficiency.

By joining this webinar, you will not only stay ahead of the regulatory curve but also equip your organization with the knowledge to implement a modern, compliant, and efficient validation strategy that leverages the full potential of current and emerging technologies. Gain the insights needed to transform your validation approach, aligning with the FDA’s current expectations and preparing for the future of software assurance in the life sciences 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 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 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: GAMP5, FDA CSA, System Validation, Compliance, Life Sciences, Agile Methodology, Risk Management, Software Assurance, Quality Systems, Regulatory Guidance, Carolyn, Troiano, April 2024, Webinar