The System Development Life Cycle Methodology to Support Computer System Validation and FDA Compliance

Carolyn Troiano is Keynote Speaker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. Carolyn has participated in industry conf........


This webinar will help you understand in detail the System Development Life Cycle (SDLC) Methodology and the importance of following this approach 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.

Why should you attend this webinar?

This webinar is intended to provide the attendee with a thorough understanding of the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV). The SDLC framework will help you put together a systematic and organized way of conducting effective and efficient validation efforts, including the deliverables and other documentation required for FDA compliance.
The webinar will take you through planning, execution, and management of a computer system validation effort, applying the SDLC methodology to maximize compliance while minimizing cost.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.

Areas Covered in the Session:

This webinar will cover the following key areas:

Who can Benefit:

  • Computer System Validation Specialists
  • Information Technology Professionals
  • Automation Analysts and Managers
  • QC/QA Analysts and Managers
  • Laboratory Analysts and Managers
  • Manufacturing Analysts and Supervisors
  • Supply Chain Managers and Analysts
  • Compliance and Audit Managers
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers

Webinar Id: LSHCCT0014

Training Options:

Duration: 90 mins

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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