In today’s rapidly evolving technological landscape, companies are compelled to reconsider their business strategies. Once highly organized and regulated, these businesses now navigate a more chaotic and complex environment, catering to patients and consumers who are better informed and have higher expectations than ever before. To meet these challenges, work habits and equipment must be adapted accordingly.

To stay ahead of these changes, it is crucial to pay close attention to software development, validation processes, and maintaining system validation throughout the entire lifecycle. This webinar, led by industry expert Carolyn Troiano, will compare the waterfall and agile approaches, highlighting the benefits and drawbacks of each. While there may not be a one-size-fits-all solution, understanding the key factors to consider when making such decisions is essential.

Carolyn will map both waterfall and agile methodologies to the GAMP®5 "V" Model, providing a roadmap for successful system validation in each scenario. The second edition of GAMP®5, published in July 2022, aligns well with the FDA Draft Guidance on Computer Software Assurance (CSA) issued in September 2022. We will explore the pros and cons of Computer System Validation (CSV) and CSA, emphasizing the importance of incorporating GAMP®5 best practices into the validation process.

Additionally, she will discuss cloud services, including IaaS, PaaS, SaaS, and COTS, outlining the advantages and disadvantages of each model. Best practices for meeting FDA validation criteria, 21 CFR Part 11 compliance, and data integrity will be covered, addressing the FDA's current concerns and providing tips to ensure your systems meet their standards.

The FDA is encouraging the adoption of modern technology to foster corporate innovation. As part of the Case for Quality program, the US FDA Center for Devices and Radiological Health has highlighted how an overemphasis on regulatory compliance can divert resources and managerial attention away from automation and digital technologies that can significantly improve quality and process control.

A key element is the risk-based, product quality, and patient-centric approach to Computer System Assurance (CSA), as outlined in the draft guidance issued in September 2022, versus the traditional CSV waterfall approach. CSA favors a critical thinking approach based on product and process knowledge and quality risk management, over the prescriptive, documentation-driven methodologies of CSV. Additionally, it advocates for the use of automated testing to enhance validation efficiency and effectiveness.

The FDA has concluded that the "WHAT" requirements can be met through various "HOW" methods, moving away from the checklist approach of traditional CSV that focuses on document production without considering potential requirement failures.

For custom application development, GAMP®5 supports incremental, iterative, and evolutionary methodologies, including automated and agile testing. Keys to success include a robust Quality Management System (QMS), well-trained and highly disciplined teams, and well-defined processes supported by tools and automation.

Join Carolyn Troiano for this informative session to gain insights and practical knowledge on adapting your systems and processes to meet the evolving demands of the industry.

Webinar Objectives

In this session, participants will:

• Understand the FDA's Technological Strategy: Gain insights into the FDA's approach to modernizing technology, focusing on how these updates benefit both the business community and the Agency itself.
• Explore Automated Testing Tools: Learn how to utilize automated testing tools for continuous validation of software products, enhancing the traditional System Development Life Cycle (SDLC) approach to Computer System Validation (CSV).
• Adapt Agile Methodologies for Validation: Discover how agile software development techniques can be modified and applied for validation purposes, and examine the benefits and drawbacks of different strategies.
• Examine Industry Best Practices: Review successful industry best practices for implementing modern validation approaches, ensuring compliance and efficiency.
• Evaluate Cloud Services and Solutions: Understand the different types of cloud services, including Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), Software-as-a-Service (SaaS), and Commercial off-the-Shelf (COTS) software.
• Choose the Best Solutions: Learn how to select the most suitable cloud solutions for your needs and how to create tailored contracts and Service Level Agreements (SLAs) to fit your specific environment.

By the end of the session, attendees will be equipped with the knowledge and tools to effectively integrate modern technology and validation methods into their business processes, ensuring compliance and operational excellence.

Webinar Agenda

• Learn how to identify “GxP” Systems
• Learn about FDA’s current thinking about technology and software development, and how this will impact industry
• Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements and the Computer Software Assurance (CSA) approach, based on the draft guidance from FDA in September 2022
• Learn about GAMP®5, Second Edition and how it aligns more closely with the CSA approach to validation
• 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
• Learn about cloud services and cloud service providers to optimize your experience
• Learn ways to validate in the cloud without compromising quality or compliance
• Learn the pros and cons of an agile vs. waterfall approach
• We will discuss cloud computing, Computer Off-the-Shelf (COTS) software validation, and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectively
• Talk about the best ways to manage related documentation more effectively and efficiently when documenting computer system validation efforts, whether they are done using an agile or waterfall methodology. This includes requirements, design, development, testing, and operational maintenance procedures.
• Understand the best approach to Installation Qualification (IQ) testing when the system components are not on premise, but in the cloud
• Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an Agile continuous validation approach
• 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

Webinar Highlights

• Gain an understanding of how mobile applications should be handled when performing validation work
• Understand the best practices for maintaining a mobile application in a validated state
• Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately
• Learn how to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk
• Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications
• Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge
• Understand some of the key “pitfalls” to avoid when applying the concepts of computer system validation to mobile applications

Who Should Attend

• Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:
• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA
• Personnel in the following roles will benefit:
• Information Technology Analysts, Developers, Testers, Support Personnel
• 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