FDA Compliance And Laboratory Computer System Validation
Learn to plan, run and manage FDA-compliant laboratory computer system validation using the SDLC and GAMP 5, with the documentation that keeps systems validated at lower cost.
Speaker
Carolyn Troiano
Computer system validation consultant · 35+ years in computer system validation
Overview
Laboratory computer system validation is critical for any FDA-regulated organization, but the volume of guidance can be overwhelming. This 90-minute webinar condenses decades of industry best practice into the methods, techniques and tools that give compliant results at the lowest cost.
Using the System Development Life Cycle (SDLC) framework, you'll learn how to plan, execute and manage validation of laboratory systems, and how GAMP 5 categories shape the validation approach, especially testing. You'll review the key documentation needed to validate systems and keep them in a validated state.
The session also covers building a standardized program across all FDA-regulated systems, training for business and IT staff, business process re-engineering opportunities when replacing legacy systems, and why formal organizational change management helps users adopt new technology.
Why attend: Best practices developed over the past 30 years can make laboratory system validation efficient and compliant, if you know which ones matter most. This course points you to the most critical and cost-effective approaches. It suits IT analysts, developers and testers, QC/QA staff, analytical chemists, lab, compliance and audit managers, automation analysts, CSV and GMP training specialists, business stakeholders and life sciences consultants who plan, run, manage or support FDA-regulated systems.
What’s covered
- Laboratory computer system validation planning, execution and management
- Best practices for compliant results at minimum cost
- Identifying the system's GAMP 5 category to guide validation and testing
- Key documentation for validating laboratory systems and keeping them validated
- Creating a standardized program across FDA-regulated systems
- Training for business and IT staff involved in validation
- Business process re-engineering opportunities when implementing a new system
- Using formal organizational change management to support user adoption
- Q&A
Who should attend
What you get
About the speaker
Carolyn Troiano has more than 35 years of experience in computer system validation 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. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
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