Overview: 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.
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.
Reference material for easy implementation:
SOPs: Validation of Commercial Off-the-Shelf Computer Systems
Checklist: Using computers in FDA regulated environments
Validation examples from planning to reporting
Areas Covered in the 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