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This course gives an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements. Also covered are major areas subject to regulatory inspections and audit by the FDA and other international agencies. Samples of assessment tools are provided.
This course is designed for individuals seeking an understanding of computer system validations and/or professionals in the biotechnology industry with experience in Production and/or Quality Management seeking to apply these concepts at work.
This 1 day, 8 hour course covers the following topics:
- Regulations and Guidance Related to Computer Systems
- Quality Management Systems
- Computerized System Life Cycle Phase
- Validation Test Development
- Types of Qualification (DQ, IQ, OQ, PQ)
- Documentation Requirements/GMPs
- 21 CFRs
- Master Plans
- Standard Operating Procedures (SOPs)
- Contents of Validation Reports
Upon successful completion, participants will be able to:
- Describe the regulatory requirements for computer validation
- Identify criteria for determining system validation
- Explain the major functions to test during validation
- Differentiate key components and phases of computer validation
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