Virtual networks and cloud computing can significantly reduce investment and operating costs for IT operations. However when used in FDA and other regulated environments they need to be qualified to ensure consistent on-going performance and security and integrity of stored and managed data. While there are guidelines available on how to deal with standard networks this is not the case for virtual networks and cloud computing.
Areas Covered in the Seminar:
* Benefits and compliance issues of virtual networks and cloud computing
* Possible issues when used in FDA regulated environments
* Recommendations from official task forces
* Infrastructure qualification vs. system validation
* How to deal with major issues: security, data availability and data integrity
* Going through a complete project for virtual network qualification
* Specific considerations for change control
* Issues with different cloud versions: internal/external private, public
* Recommendations for different cloud services: platform, infrastructure and software
* Responsibilities:
* Step-by-step recommendations for cloud computing from planning to reporting
* Putting everything together: documentation for the FDA and every other agency
Date: February 9,2011
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide
Who should attend
* IT managers and personnel
* Everybody responsible for FDA compliance of computer systems
* Managers from purchasing, documentation and operations
* Validation groups
* QA managers and personnel
* GLP/GMP/GCP auditorsConsultants
* Teachers
Weblink: http://www.labcompliance.com/
Presenter: Dr. Ludwig Huber
Category: Pharmaceutical, FDA, validation
