In-Depth Testing of Computer Systems Regulated by FDA


In-Depth Testing of Computer Systems Regulated by FDA is a webinar that covers topics such as:

  • 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

In-Depth Testing of Computer Systems Regulated by FDA is intended for:

  • 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

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Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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