Validation and Use of Cloud Computing in FDA Regulated Environment

Duration: 75 Minutes
This webinar will give a good understanding of FDA and equivalent international requirements for cloud computing.
Benefits of Cloud Computing
Instructor: Dr. Ludwig Huber
Product ID: 500989

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 and computer systems this is not the case for virtual networks and cloud computing.

Why Should you Attend
Attendees will be able to understand different cloud models, to decide which can be used in FDA and equivalent international environments, and to manage cloud projects for regulated environments.

Objectives of the Presentation
  • 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
Who can 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
  • GLP/GMP/GCP Auditors
  • Teachers
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ludwig Huber, Ph.D., is the director of Lab compliance, 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 more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.


View More