Cost-Effective Computer System Validation: Step-by-Step - GlobalCompliancePanel

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

Who Will Benefit:
IT Managers and System Administrators
QA Managers and Personnel
QC and Lab Managers
Validation Specialists
Regulatory Affairs
Training Departments
Documentation Department
Consultants

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

GlobalCompliancePanel
Phone: 800-447-9407
Fax: 302-288-6884

[email protected]
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801