This webinar will cover all aspects of testing to ensure that a computer system regulated by FDA "does what it purports to do," as per the guidance on computer system validation (CSV) from FDA, first issued in 1983.
It will also touch on elements of testing necessary to ensure compliance with 21 CFR Part 11, FDA's guidance on electronic records and electronic signatures (ER/ES) published in 1997. We will cover all of the required policies and standard operating procedures (SOPs) to support the testing effort.
We will also provide guidance on the set of documented evidence necessary to both support your validation effort, and ensure your computer systems that are regulated by FDA are maintained in a validated state.
Most recently, FDA has focused its resources and efforts on the area of data integrity, as this can lead to problems with product quality, and ultimately, patient or consumer safety.
This webinar will cover some of the FDA's recent compliance and enforcement trends to enable you to understand the best way to build quality practices into your validation and testing efforts and comply with all FDA requirements.
Why should you Attend
The attendees will learn about the testing component of Computer System Validation (CSV) work that's aligned with the System Development Life Cycle (SDLC) Methodology. This includes:
- Determining the category of your system, based on GAMP 5 from ISPE
- Determining the risks associated with the various ways your system may fail
- Using the category and risk, develop a rationale for the level of testing that will be needed to assure your system is thoroughly vetted
- Understand the FDA requirements for documentation of all testing activities
- Understand how to write a test protocol for each phase of testing:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ) [also referred to as User Acceptance Testing, or UAT]
- Understand how to develop test scripts and acceptance criteria
- Learn how to identify test discrepancies and distinguish the type:test script errors, tester errors,system errors
- Learn how to document all testing and the summary reports Learn about maintaining the system in a validated state, and keeping testing as a 'living' exercise that runs through the system life cycle
Areas Covered in the Session
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
- Validation Strategy that will take into account the system risk assessment process and GAMP 5 system categorization to analyze the best approach to testing
- Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way, and include only those that you are going to use to minimize testing requirements
- System Design Specification (SDS) that details how the functional requirements will be delivered
- Test Planning, including Development of Scenarios, Cases and Scripts (Installation Qualification, Operational Qualification and Performance Qualification)
- Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements
- System Acceptance and Release Notification
- Ongoing validation maintenance and governance
- System Retirement steps to close out the life cycle
Who Will Benefit
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Laboratory Managers
- Automation Analysts
- Manufacturing and Supply Chain Managers and Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
- Business System/Application Testers in FDA-Regulated Functional Areas
This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.