In-Depth Testing of Computer Systems Regulated by FDA

Why Should You Attend:

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.

Testing is one of the most crucial aspects of computer system validation, and must be planned, executed and documented carefully.

Preparedness will also help improve your relationship with the agency and ensure a more cooperative and successful audit experience. You will be in a very solid position to defend your validation efforts and the underlying systems and data. The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process.

Areas Covered in the Webinar:

This course includes the following key areas of learning:

• 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

Who Will Benefit:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biotechnology, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling, Quality testing, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any GxP system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

• Data “Owners”
• Data “Stewards”
• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• GLP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers

This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 30 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.

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