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Validation and Use of Cloud Computing in FDA Regulated Environments

Event Details

Validation and Use of Cloud Computing in FDA Regulated Environments

Time: July 25, 2013 from 11am to 12pm
Location: Online
Website or Map:…
Event Type: webinar
Organized By: Dr. Ludwig Huber
Latest Activity: Jun 17, 2013

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Event Description

This web-seminar will discuss how to combine the cost benefits of modern IT Cloud computing with requirements of FDA and equivalent interntional agencies.

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.

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

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

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

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I made this website primarily because of the evolution I see the pharmaceutical industry is going through. For the fact that there are so many talented, experienced, and motivated pharmaceutical professionals with expertise in a wide variety of life sciences fields who have the ideas and the capabilities to establish new companies but are not able to acquire the funds to take them off the ground. And I believe that only by facilitating the start up of these new companies and organizations we can ensure the health and prosperity of our industry.

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What I am Hoping This Site to Accomplish
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