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

For over three decades, the FDA has regulated computer system validation in industries like pharmaceuticals, biotechnology, and medical devices. These validations ensure that computer systems involved in production, testing, and distribution operate securely and reliably. Recently, the FDA has taken a major step forward with its Technology Modernization Action Plan (TMAP), aimed at modernizing the way the agency works with the industry. This development marks a shift in focus from merely validating existing systems to also incorporating new technologies such as cloud computing and Software as a Service (SaaS).
 
With an increasing focus on data integrity, the FDA's modernization plan seeks to set higher compliance standards for all regulated computer systems. This focus isn't just limited to structured data; it extends to unstructured data formats like documents, spreadsheets, and even audio-visual files. Given these evolving guidelines, it is vital for companies in regulated industries to keep pace with the FDA's expectations on computer system validation and data integrity.
 
In light of these developments, this webinar will focus on deciphering the FDA's Technology Modernization Action Plan and its impact on computer system validations. We will also discuss how to integrate modern technologies into your compliance strategy without compromising data integrity.

• Learn how to identify “GxP” Systems
• Learn about the FDA’s current program for the modernization of technology, and how this will impact the industry
• Learn about the FDA’s Technology Modernization Action Plan (TMAP), including what work is underway and what is planned in the near term
• Discuss the current state of the Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
• We will discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures, including ways to improve efficiency and effectiveness
• Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner.
• Learn how to ensure the integrity of data that supports GxP work, despite changes and advances in new technology
• Discuss the importance of “GxP” documentation that complies with FDA requirements
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

As the FDA continues its technology modernization through the Technology Modernization Action Plan (TMAP), the complexity around Computer System Validation (CSV) is increasing. This webinar provides an invaluable guide to navigating this evolving landscape. Grounded in the System Development Life Cycle (SDLC) Methodology, the session offers a structured framework for planning and implementing your validation strategy, which will withstand FDA scrutiny and assure data integrity throughout a system's entire life cycle.
 
Maintaining a system in a validated state is as vital as the initial validation. This training program will delineate the policies, procedures, and training elements essential for ongoing system maintenance in a validated state, mitigating any potential risks.
 
In addition, Data Integrity (DI) has come under the FDA's spotlight, especially during inspections. Over the last decade, DI-related issues have increasingly led to Form 483 citations and Warning Letters. This webinar will equip you with industry best practices and the current regulatory requirements related to DI, setting you up for successful FDA inspections.

• 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.