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Validation and Use of Cloud Computing in FDA Regulated Environments - Webinar (Recorded)

  • Webinar

  • 90 Minutes
  • November 2018
  • Compliance Online
  • ID: 4899770
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


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.