Web Seminar: Validation and Use of Cloud Computing in FDA Regulated Environments

This web seminar will discuss how to how to combine the cost benefits of modern IT Cloud computing with requirements of FDA and equivalent interntional agencies. Attendes will receive 10+ best practice guides for easy implementation.
Speaker Dr. Huber in a panel discussion with FDA's Part 11 expert: George Smith
Speaker Dr. Huber in a panel discussion with FDA's Part 11 expert: George Smith
Sept. 20, 2012 - PRLog -- Why to 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 seminar will have the answers. During the seminar, the speaker will present validation and compliance strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help trouble-free implementation.

Date:  July 25, 2013
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide

Weblink:  http://www.labcompliance.com/seminars/audio/317/default.aspx

Areas Covered in the Seminar:

* 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

And for easy and instant implementation:
download 10+ documents from special seminar website.
They include

* SOP: Qualification of Virtual Networks
* SOP: Using Cloud Computing in Regulated Environments
* SOP: Using the Internet in Regulated Environments
* SOP: Validation of Web-Based Applications
* SOP: Development and Maintenance of Test Scripts for Equipment Hardware&Software
* Example and example: Testing Authorized System Access
* Template and examples: Network Infrastructure and System Identification
* NIST Guidelines related to Cloud Computing (link)
* Transcript FDA Presentation: Virtualization and Cloud Computing, (link)
* White Paper: Virtualization and Risk: Key Security Considerations for Your Enterprise Architecture (link)
* PowerPoint Presentation
* Script of the presentation
* All questions and answers from before, during and after the seminar

Who should attend
* 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
* Consultants
* Teachers

Category: Pharmaceutical, Clinical Research Oragnisations, FDA, Training, Stabilty testing, Laboratories, Medical devices, Contract Laboratories

Presenter: Dr. Ludwig Huber

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the global on-line resource for validation and (laboratory) compliance. Dr. Huber has been presenting more than 200 web, video and audio seminars. He has been selected as IVT's "Presenter of Year" out of 175 presenters. He is also the author of more than 100 papers about FDA and international compliance (including the bestselling books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories)”. Currently, Dr. Huber is on the Scientific Advisory board of IVT’s GxP and Validation Journals, and he has given multiple presentations and workshops mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included workshops and presentations for the  US FDA, ISPE, PDA, PDA, PIC/S and several national health agencies including China SFDA

For more information, please visit Dr. Huber's Website

Email:***@labcompliance.com Email Verified
Tags:Fda, Compliance, Cloud, Validation, Qualification, Networks, Computer, Infrastructure
Industry:Pharmaceutical, API-Manufacturer, Medical device
Location:United States
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Page Updated Last on: Jun 24, 2013

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