This webinar will focus on the efforts by FDA to modernize its own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.
We will also discuss FDA’s more recent push to Software Quality Assurance (SQA) and away from traditional Computer System Validation (CSV), which is based on the System Development Life Cycle (SDLC) methodology. FDA is stressing the importance of the industry understanding what is required to be in compliance and thinking critically about new ways to achieve that. We will cover automated testing and continuous validation as key components of the SQA approach.
WHY SHOULD YOU ATTEND?
The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.
We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.
AREA COVERED
- 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 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 assure 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
WHO WILL BENEFIT?
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors responsible for software development, testing, and maintenance
- Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.
We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.
- 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 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 assure 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
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors responsible for software development, testing, and maintenance
- Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
