Validation and Use of Cloud Computing in FDA Regulated Environments

Why Should You Attend:

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 validated 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.

This webinar will give a good understanding of FDA requirements related to cloud computing and provide recommendations for implementation.

Areas Covered in the Webinar:

• Benefits of virtual networks and cloud computing
• Possible issues when used in FDA regulated environments
• Recommendations from official task forces
• Different models: infrastructure, platform and software as a service
• Recommendations for different cloud versions: internal/external private, public
• Validation of cloud vs. traditional computers
• How to deal with major issues: security, data availability and data integrity
• Going through a complete project for cloud computing validation
• Selecting the right cloud provider for compliance
• What and how much to test and documents for different cloud models
• Considerations for formal agreements with service providers
• Step-by-step recommendations for using 'clouds' from planning to reporting
• Putting everything together: documentation for the FDA and every other agency
• Sharing best practices

Hand-outs

For easy implementation, attendees will receive:

• SOP: Using Cloud Computing in Regulated Environments
• SOP: Using the Internet in Regulated Environments
• SOP: Qualification of Virtual Networks

Who Will Benefit:

• IT managers and personnel
• Everybody responsible for FDA compliance of computer systems
• Managers from purchasing, documentation and operations
• All users of computer systems used in regulated environments
• QA managers and personnel
• LP/GMP/GCP auditors
• Consultants

Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

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