Upon completion of this session, attendees will have an understanding of computer system testing concepts and how these efforts are to be adequately documented to meet FDA requirements.  They will understand the steps required for documenting the test planning, execution results and summary reporting.  The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program for testing.

Course Objectives:

• Learn about industry best practices for developing a validation program that includes planning, execution and maintenance components, involving specific testing, that will ensure these efforts will meet all regulatory agency requirements and expectations
• Learn all about how to prepare your system validation documentation, including test protocols, scripts, and summary reports for an FDA audit of your company’s computer systems
• Learn how  to continue testing, through the life cycle of the computer system, as changes are made to ensure it works in the way the user will challenge it during day-to-day operations

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.

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Quality Managers, Chemists and Microbiologists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries