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GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Carolyn Troiano
Recording Webinar Available @All Days
Recorded Webinar
  

Description

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of the importance of compliance with systems used in regulated industries. These include all systems that “touch” products, meaning they are used to create, collect, analyze, manage, transfer, and report data regulated by FDA.  All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio, and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

We will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover the FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment, that can be leveraged to assist in all your GxP work. These will be presented in the context of applying GAMP®5, Second Edition, and CSA.

Learning Objectives:-

  • 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 the validation of mobile applications, as the 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

Areas Covered:-

  • Learn how to identify “GxP” Systems
  • Understand GAMP®5 (Second Edition) and the best practices that will impact your validation work
  • Discuss the Computer System Validation (CSV) approach based on FDA requirements
  • Learn about the System Development Life Cycle (SDLC) approach to validation
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures
  • Understand how to maintain a system in a validated state through the system’s entire life cycle
  • Learn how to assure the integrity of data that supports GxP work
  • 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.

Background:-

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing, and management of computer systems used to collect, analyze, and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997 and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP®5 category, and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

Until recently, the traditional approach to Computer System Validation (CSV) was believed to be required by FDA. It was also believed that following GAMP®5 practices was also a requirement. While FDA will tell the industry WHAT is required, they have never dictated HOW those requirements should be met. Each company that is FDA-regulated must use critical thinking, as described in the CSA approach to come up with the most practical and innovative way to adhere to the regulations. They still must meet WHAT FDA requires, but HOW must be evaluated and determined in order to comply.

GAMP®5, Second Edition aligns well with CSA, and the two used in concert can provide a more effective and efficient means of reaching compliance for computer systems used in regulated processes.

Why Should You Attend:-

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.).

Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition, published in July 2022, and CSA, a new approach that is the subject of a Draft guidance from the FDA that was issued in September 2022. These two guidances will reshape the way companies handle the validation of computer systems that are based on newer and more innovative technologies.

  • 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
  • Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
  • Know the regulatory influences that lead to FDA’s current thinking
  • Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
  • Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP®5 category, and risk, should it fail, to develop a cohesive and comprehensive validation rationale
  • Learn how to best prepare for an FDA inspection or audit of a GxP computer system
  • Understand the importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver
  • 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 Analysts
  • Information Technology Developers and Testers
  • Software Quality Assurance Professionals
  • 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

Rather than avoiding these modern breakthroughs in technology and continuing to rely on older ways of conducting business, attendees will learn how to adapt their current practices and think about validation to leverage these innovative tools and advance their ability to bring their companies to a new level of success. Newer technologies will help them bring more advanced products to the marketplace and this can be achieved by learning how to approach validation to continue meeting FDA compliance.

Training Options

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Recording
   $199  

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   $229  

Transcript (PDF)
   $199  

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