Testing for Compliant Computer Systems for FDA

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. 
In this webinar expert speaker Carolyn Troiano, will discuss 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. Speaker will also discuss the guidance for maintaining the system in a validated state and assessing the level of any testing tha0t might be required post-validation to ensure that compliance 
Session Highlights: 
  • 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
Why You Should Attend: 
In this webinar 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. This 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 
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 
  • 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 
  • Computer System Validation Specialist 

Ask your question directly from our expert during the Q&A session following the live event.
Location: United States

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