In Depth Testing of Computer Systems Regulated by FDA

Description

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

Future Events

In Depth Testing of Computer Systems Regulated by FDA 2020

Important

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

Prices are for evaluation only.

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