FDA Modernization and Restructuring of the SDLC for Computer System Validation and Compliance

Course Description:

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 that 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, and so it is important to understand what needs to be considered when making such a determination.

As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower than anticipated investment in automation and digital technologies, which could greatly improve quality and process control. 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. This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation driven approaches.

This is where FDA determined that “WHAT” is required can be done (the “HOW”) in different ways and does not have to be according to the “checklist” mindset of most CSV work, where you create documents without specifically addressing the risk of potential failure of each requirement.

GAMP5 supports the use of incremental, iterative, and evolutionary approaches including Agile, for development of custom applications. Keys to success include a robust Quality Management System and well trained and highly disciplined teams following well-defined processes supported by tools and automation.

Why Should You Attend?

The attendee will learn about 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.

Areas Covered in the Webinar:

This webinar will cover the following key areas:

  • 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
  • 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
  • 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 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 assure 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
  • Q&A

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.

  • 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

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

  • Pharmaceutical
  • Medical Device
  • Biologicals
  • 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
  • Medical Device software developers
  • Software as a Medical Device (SaaMD) software developers

Our Speaker

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

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