Computer System Validation: Step-by-Step

Why Should You Attend:

The validation of computer systems has been an FDA requirement for over 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, particularly when it comes to development of protocols. This webinar will provide attendees a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. It will also detail the structure of a validation plan with examples.

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

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

Who Will Benefit:

• Personnel from the pharmaceutical and medical device industry
• Manufacturers of pharmaceutical ingredients
• Contract manufacturers and laboratory staff
• IT managers and system administrators
• QA managers and personnel
• QC and lab managers
• Validation specialists
• Regulatory affairs personnel
• Training department personnel
• Documentation department personnel
• Consultants