In-Depth Testing of Computer Systems Regulated by FDA 2019 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 2019 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
