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Validity : 21st Apr'24 to 01st May'24
In Depth Testing for FDA-Regulated Computer System Validation Compliance
- Determine the category of your system, based on GAMP 5 from ISPE
- Determine the risks associated with the various ways your system may fail
- Use 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
- Q&A
Overview of the webinar
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. You’ll learn all about how to prepare your system validation documentation for an FDA audit of your company’s computer systems.
One of the most critical aspects of validation is the testing phase, which includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). A protocol must be prepared and followed for each one, along with a summary report. These activities will ensure the system is properly installed, and that not only does the core functionality work, but it works in the way the user will challenge it during day-to-day operations.
Who should attend?
- Information Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices
Why should you attend?
The Webinar will focus on testing as a key element of Computer System Validation (CSV). The level of testing must reflect both the potential risk associated with failure of the system to function properly. It must also be based on the systems’ classification in accordance with GAMP 5.
You will learn the way to develop a detailed rationale for testing and how to ensure that it is fully executed and documented in accordance with FDA requirements. You will also be provided with guidance for maintaining the system in a validated state and assessing the level of any testing that might be required post-validation to ensure that compliance.
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.