By : Compliance Online
Date : 2012
Location : California / Palo Alto
Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report.
computer validation, FDA requirement, warning letters
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.
Areas Covered in the Seminar:
- 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.
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 email@example.com for these documents and they will be emailed to you within 4 working days.
Who Will Benifit:
- Pharmaceutical and medical device industry
- Manufacturers of pharmaceutical ingredients
- Contract manufacturers and laboratories
- IT managers and system administrators
- QA managers and personnel
- QC and Lab managers
- Validation specialists
- Regulatory affairs
- Training departments
- Documentation department
Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Lab Compliance , 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.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria