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FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

You'll learn about the various computer system validation deliverables and how to document them through the entire process. You will learn about what must be done to ensure the system remains in a validated state. In addition, you'll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology.

You'll also learn about recent FDA inspection trends and the key areas of CSV that could be scrutinized more heavily. This webinar will help you fortify your CSV program and documentation for compliance inspection success.

Why should you Attend

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.

It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered. You should also attend to learn the key areas most scrutinized by FDA during inspection to prepare for future audits.

Areas Covered in the Session

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good"Variable" Practice (GxP) (Good Manufacturing
    Practice (GMP), Good Laboratory Practice, Good Clinical Practice (GCP)
  • Validation Planning
  • GAMP 5 System Classification
  • Risk Assessment
  • Functional Requirements Specification
  • Configuration and Custom Coded Solutions
  • Installation Qualification (IQ) Testing
  • Operational Qualification (OQ) Testing
  • Performance Qualification (PQ) Testing (User Acceptance Testing/UAT
  • Validation Summary Report
  • Operational Maintenance for Validated Systems
  • Policies and Procedures
  • Training
  • Organizational Change Management (OCM)
  • Periodic System Review
  • Disaster Recovery and Business Continuity Planning
  • System Retirement
  • FDA Recent Inspection Trends and Key Areas of Focus

Who Will Benefit

  • Information Technology (IT)Analysts
  • IT Developers
  • IT Support Staff
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders using Computer Systems Regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns Working at the companies listed above
  • College students attending schools and studying Computer System Validation, Regulatory Affairs/Matters (related to FDA) or Any Other Discipline that Involves Adherence to FDA Regulatory Requirements

Speaker Profile

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

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.