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Learn the process for validation of automated equipment and process control systems typically found in the biomanufacturing or pharmaceutical facilities using GAMP 5 and other guidelines. Highly interactive activities including discussion of case studies and hands-on development of documentation are provided.
This course may be taught at any location.
This 2 day,16 hour course, covers the following topics:
- Types of automated equipment/process control systems
- GMPS and regulatory requirements
- Industry guidance documents/ documentation requirements
- Part 11- Electronic Records/Signatures
- GAMP 5 Life Cycle
- Risk and Impact Assessments
- Validation test plan and development
- Creating validation documentation
- Handling discrepancies/deviations during testing
- Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Maintaining the validated state
Upon successful completion participants will be able to:
- Determine risk assessments and test acceptance criteria based on guidance documents, the validation life cycle, requirements and system specification documents.
- Develop test documentation for automated equipment and process control systems validation.
- Demonstrate capabilities in testing and accurately reporting discrepancies/deviations and conclusions to meet regulatory audit expectations including traceability of testing performed as needed for audits.
This course is designed for individuals seeking an understanding of automated equipment and process control system validations. The class is suitable for individuals seeking industry training in developing validation programs and also offers a review of the fundamentals of computer system hardware and software, how to manage electronic data and to be in compliance with GAMP 5 and meet FDA requirements.