As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their 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.
Why Should You Attend:
You 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.
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 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.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.
Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11 . This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.
Areas Covered in the Webinar:
- Learn how to identify “GxP” Systems
- Learn about FDA’s current program for modernization of technology, and how this will impact 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 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
Who Will Benefit:
This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.
Examples of who will benefit from this webinar include:
- 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
