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.
For easy implementation, attendees will receive
- SOP: Validation of Commercial Off-the-Shelf Computer Systems
- SOP: Development and Maintenance of Test Scripts for Software and Computer Systems
- Checklist: Using computers in FDA regulated environments
- 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
A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of pharmaceutical ingredients and Contract manufacturers and laboratories. The teams that will benefit the most are:
- IT Departments
- QA Departments
- QC Lab Departments
- Validation Specialists
- Regulatory Affairs Departments
- Training Departments
- Documentation Departments
- Consultants
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