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Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers who are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

The approach to developing software, performing validation, and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This webinar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, so it is important to understand what needs to be considered when making such a determination.

Learning Objectives:-

Learn how to identify “GxP” Systems
Learn about FDA’s current thinking about technology and software development, and how this will impact the industry
Discuss the current state of the Computer System Validation (CSV) approach based on FDA requirements
Understand traditional CSV as it compares with Computer Software Assurance, the latest DRAFT guidance from the FDA
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 the pros and cons of an Agile vs. Waterfall approach
Learn about cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively, along with other newer technology products, services, and platforms
Understand the best practices for documenting computer system validation efforts, whether using a Waterfall or Agile approach, including requirements, design, development, testing, and operational maintenance procedures, including ways to improve the efficiency and effectiveness of managing related documentation
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 ensure the integrity of data that supports GxP work, despite changes and advances in new technology
Understand 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

Areas Covered:-

Computer System Validation (CSV)
Computer Software Assurance (CSA)
Waterfall Methodology
Agile Methodology
System Development Life Cycle (SDLC) Methodology
GAMP®5 2nd Edition
GAMP®5 “V” Model
Automated Testing
Critical Thinking
Cloud Computing
Software as a Service (SaaS)

A key element is a risk-based, product quality, and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) Waterfall approach.

The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and the 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. This approach is amenable to the Agile software development methodology, which can be adapted for use in validation.

We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.

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