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The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation.
Areas Covered in this session:
- US FDA and EU requirements and enforcement practices
- Learning from recent FDA 483's and warning letters
- Selecting the right validation model: qualification vs. verification
- Eight fundamental steps for computer system validation
- Structure and example of a validation plan
- Justification and documentation of risk levels
- Example qualification document for suppliers of commercial systems
- Examples for requirement and functional specifications?
- Example for IQ protocols
- OQ test protocols: development, execution, approval - examples
- Documentation of ongoing performance
- Validation of existing systems
- Structure and example of a validation report
- Step-by-step case studies from laboratories and manufacturing for easy implementation.
Who should attend:
- QC managers
- QA managers and personnel
- IT administrators
- Regulatory affairs
- Training departments
- Validation groups
- Documentation department
Ludwig Huber, Ph.D., is the director of Lab compliance, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, , ISPE, Japan PDA, PIC/S and several other national health care agencies.