FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity

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.

• Identify GxP systems that need validation
• Explain what TMAP is and how it affects regulated computer systems
• Apply an SDLC-based, more agile validation approach, including automated testing
• Validate cloud computing and SaaS systems effectively
• Document validation work in line with FDA requirements
• Maintain systems in a validated state across their life cycle
• Protect data integrity using risk-based best practices

• 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

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.

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection of labeling records and practices

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.