FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
Learn what the FDA's TMAP means for computer system validation, how to validate cloud and SaaS systems, and how to keep GxP data integrity intact across the system life cycle.
Speaker
Carolyn Troiano
Computer system validation consultant · 35+ years in computer system validation
Overview
The FDA has regulated computer system validation in pharmaceuticals, biotechnology and medical devices for more than 30 years. With its Technology Modernization Action Plan (TMAP), the agency is changing how it works with industry, moving beyond validating existing systems toward newer technology such as cloud computing and Software as a Service (SaaS).
This 90-minute webinar explains what TMAP involves and how it affects validation of regulated computer systems. The FDA's data integrity focus now reaches unstructured data too, including documents, spreadsheets and audio-visual files.
You'll learn how to bring modern technology into your compliance strategy, use an SDLC-based and more agile validation approach, and keep systems validated without putting data integrity at risk.
Why attend: As TMAP moves forward, computer system validation (CSV) is getting more complex, and data integrity problems have increasingly led to Form 483 observations and Warning Letters over the last decade. This session gives you a structured, SDLC-based framework for validation that stands up to FDA scrutiny, plus the policies, procedures and training needed to keep systems in a validated state. It is aimed at IT, QA/QC, clinical data, laboratory, manufacturing and validation staff, as well as consultants and auditors involved in regulated computer systems.
What’s covered
- Identifying GxP systems
- The FDA's current technology modernization program and its impact on industry
- TMAP: work underway and plans for the near term
- The current state of computer system validation (CSV) under FDA requirements
- Modernizing the SDLC validation approach with agile methods and automated testing for continuous validation
- Validating cloud computing and SaaS systems
- Documenting CSV efforts: requirements, design, development, testing and operational maintenance, with ways to work more efficiently
- Keeping a system validated through its full life cycle at lower cost
- Protecting the integrity of GxP data as technology changes
- GxP documentation that meets FDA requirements
- Policies and procedures that support validation and ongoing maintenance
- Regulatory influences behind the FDA's current thinking
- Risk-based industry best practices for validation and data integrity across the data life cycle
- 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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