In Depth Testing of Computer Systems Regulated by FDA 2019

Topics

• Key premises of the FDA regulatory oversight
• Definition and examples of GxP systems
• Key elements of SDLC
• Definition and key takeaways of CSV
• Software categorization: Specific criteria and rationale
• Risk assessment to plan and execute testing
• GAMP 5 "V" model
• IQ/OQ/PQ and testing
• Validation plan and test plan requirements
• Use of vendors and contractors
• Handling result deviations
• Testing protocol and examples
• Requirements traceability matrix (RTM)
• Test documentation requirements
• System acceptance and notification
• Preparing a testing summary report
• Training
• Standard operating procedures and templates
• Conducting periodic reviews

Who should Attend

• QC/QA managers
• Information technology analysts
• Clinical data managers
• QC/QA analysts
• Analytical chemists
• Clinical data scientists
• Laboratory managers
• Compliance managers
• Computer system validation specialists
• Automation analysts
• Business stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• GMP training specialists
• Auditors engaged in the internal inspection of labeling records and practices
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Supply Chain Managers and Analysts
• Manufacturing Analysts and Supervisors