Overview

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

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 invalidation.

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

Webinar Takeaway

  • 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
  • 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

  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above
  • College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA), or any other discipline that involves adherence to FDA regulatory requirements

Faculty Carolyn Troiano

Award winning FDA Compliance Expert for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.

My experience includes 40+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.

Ms. Troiano has specific expertise in Computer System Validation (CSV), 21 CFR Part 11, FDA’s Guidance on Electronic Records and Electronic Signatures (ER/ES), and Data Integrity. She received her MBA from Rutgers University and a BS in Toxicology from St. John’s University.

1.5 RAC CREDITS

RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria

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