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 seminar 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 crank out 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 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. 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.
  • “GxP” Systems
  • Computer System Validation (CSV)
  • Computer Software Assurance (CSA)
  • System Development Life Cycle (SDLC)
  • CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
  • Validation deliverables, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.
  • Develop a cohesive and comprehensive validation rationale
  • Comprehend a risk-based validation technique
  • Learn appropriate validation strategies for Cloud/SaaS, COTS, spreadsheets, and custom developed systems
  • Learn how to apply an agile methodology to implementation and validation work, including automated testing
  • Learn best practices for documenting validation, both for a traditional CSV and an agile approach
  • Maintain a system in a validated state
  • Learn about continuous validation through automated testing
  • Assure the integrity of data that supports GxP work
  • Policies and procedures needed to support validation
  • FDA’s current thinking and trends
  • FDA inspection or audit preparation
  • Vendor Audit
  • 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
IT, QA, & Business Managers and Professionals who need to:
  • Manage or participate on computer system projects requiring validation
  • Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
  • Understand the process of computer system validation
  • Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
  • Understand the FDA and international regulatory landscape around CSV
This seminar 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 seminar 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
  • 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
This seminar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.