Duration: 3 Hour


Purchase Options: *

Learn More

GAMP®5, the global benchmark in computerized system validation since 2008, has evolved to meet the demands of cutting-edge technologies like Artificial Intelligence, Cloud Computing, and Agile Software Development, alongside regulatory advancements such as ICH Q9 and FDA's CSA initiative. The 2nd Edition of GAMP®5 integrates crucial adaptations, emphasizing evolution over revolution, while addressing FDA's heightened scrutiny on data integrity during system validation inspections. Explore how these changes impact FDA-regulated industries and gain insights into the latest industry practices.

Gain invaluable insights into the nuances of Computer System Validation (CSV), System Development Life Cycle (SDLC) approaches, and 21 CFR Part 11 compliance for electronic records and signatures. Discover how to conduct comprehensive vendor audits to ensure the integrity of products and services delivered. With FDA's heightened focus on data integrity, learn essential strategies to safeguard structured and unstructured data throughout its life cycle. Understand the significance of risk assessment and develop robust validation rationales to mitigate potential risks effectively.

This course equips you with the tools, knowledge, and industry best practices necessary to optimize your approach to validation and compliance. Prepare to navigate FDA inspections with confidence and stay ahead of evolving regulatory requirements. This course is a transformative journey to revolutionize your approach to computer system validation and unlock unparalleled success in the ever-evolving landscape of FDA-regulated industries.

Seminar Agenda:

  • Identifying “GxP” Systems
  • GAMP®5 Second Edition – What’s Different – What’s New?
  • Understanding GAMP®5's impact on validation work
  • FDA requirements for Computer System Validation (CSV)
  • Learn about the System Development Life Cycle (SDLC) approach to validation
  • Data Integrity Assurance that supports GxP work
  • Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP®5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
  • Ensuring 21 CFR Part 11 compliance for electronic records and signatures
  • Preparing for an FDA inspection or audit of a GxP computer system
  • Conducting thorough vendor audits for product and service oversight
  • Finally, understand the industry best practices for validation and compliance, based on risk assessment, to ensure data integrity throughout the data life cycle.

Who Should Attend:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).  Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance. 

Examples of who will benefit from this webinar include:

  • Information Technology Analysts
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Specialists and Managers
  • Supply Chain Specialists and Managers
  • Regulatory Affairs Specialists
  • Regulatory Submissions Specialists
  • Clinical Data Analysts
  • Clinical Data Managers
  • Clinical Trial Sponsors
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers

This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Course Director: 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. 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.