Why Should You Attend:
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 five 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.
Hand-outs:
For easy implementation, attendees will receive:
SOPs: 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
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.
Areas Covered in the Webinar:
US FDA and EU requirements and enforcement practices
Learning from recent FDA 483s 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
Examples of 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 units for easy implementation
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 five 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.
Hand-outs:
For easy implementation, attendees will receive:
SOPs: 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
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.
Areas Covered in the Webinar:
US FDA and EU requirements and enforcement practices
Learning from recent FDA 483s 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
Examples of 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 units for easy implementation
