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Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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Testimonials

So far we have received very positive feedback from attendees of Ludwig Huber's seminars on Computer System Validation and Network Qualification. To learn how the seminar and the Labcompliance Computer System Validation package helped to validate software and computer systems, click here.

On-line Audio Seminar 332

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

Recorded, available with all reference material at any time

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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

Key Questions related to Validation of  Cloud Computing are:

  • What are the advantages and disadvantages of cloud computing
  • What are the major concerns of FDA and other agencies?
  • Do the FDA and other agencies allow the use cloud computing?
  • What are the main compliance risks for cloud storage and computing?
  • How to implement GMP requirements to cloud computing?
  • What to validate for different cloud models?
  • What exactly are the expectations of inspectors for validation?
  • How to apply risk management for cloud computing?
  • How to validate applications running on cloud computers
  • Do we need to follow a lifecycle model for validation?
  • Do the benefits of virtual networks and cloud computing justify the additional effort to comply?
  • Who is accountable for data quality, confidentiality  and integrity?
  • How to document the use virtual networks and cloud computing for the FDA?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • 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

  • 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
  • SOP: Change Control for Networks - Planned Changes
  • SOP: Change Control for Networks - Unplanned Changes
  • 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

NIST Cloud Models. Attend the seminar to learn what should be validated for each model and who is responsible for validation, data integrity, data security and availability of data.

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

Quote from FDA Presentation

"With the advent of commodity server farms and with the need for reducing costs, it's more and more imperative for industry to begin to outsource the hosting of their applications -- their in-house applications, their enterprise automation".

Attend the seminar to learn more and how to comply with FDA requirements!

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and 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, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

 Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explained FDA's next steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,

Testimonials/References

 

 

The Feedbacks on the Ludwig  Huber's seminars and validation packages have been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

 

  1. Audio Seminar: IT Infrastructure and Network Qualification: Step-by-Step
    Feedback: I'm new to the GxP IT world. The seminar was useful. I quickly gained an overview of network qualification. I would recommend the seminar to other IT professionals.
    Mr. Carmelo Rodriges, Amicus Therapeutics, Director Information Technology Department, USA, USA (Ref T-10
    05).
  2. Audio Seminar: Infrastructure and Network Qualification: Step-by-Step
    Feedback: The seminar did exceed my expectations. It was a very good seminar and I learn more from it than from the published guides on the topic
    Mr. Francois Njieha, , Kwelong, Inc., CSV Engineer, USA (Ref T-1011)..
  3. Audio Seminar: IT Infrastructure and Network Qualification: Step-by-Step
    Feedback: The seminar did exceed my expectations. All parts of networks and infrastructure that I remember were clearly addressed. Thank you and congratulations!
    Mr. Paulo Marques, Bial,  IT/IS Quality Assurance, Portugal  
    (T-1012).
  4. Audio Seminar: Cost Effective Software and Computer System Validation 
    Feedback: The seminar provided valuable information on how to proceed with validation activities in a manner that does not 'break the bank.' The information on FDA's and other agencies' current thinking will help narrow the scope of our validation activities. The templates and other reference materials will help us consolidate and streamline our current validation practices.  (Ref 1001)
    Steve Bonin, MEDTOX Laboratories, Inc.
  5. Computer System Validation Package
    The package did exceed my expectations. Very detailed. Good information. All gathered in one place. Examples and SOP documents very valuable. (Ref 1074)
    Michael Delancy, Quality Systems Engineer, Mylan Pharmaceuticals, USA
  6. Audio Seminar  Planning for Computer Systems Contingency and Disaster Recovery
    Feedback Mr Huber seemed to me very well versed on the subject. I was grateful for the detail in the presentation. I enjoyed also that he broke down who or what departments may take responsibility for various processes of the plan responsibilities. Looking forward to the next seminar
    Brian Howell, Teva Pharmaceuticals, Quality Technical Services Department, USA
  7. Audio Seminar: Master Planning for Software and Computer Validation
    Feedback: The seminar was excellent and exceeded my expectations. I expected an overview of a Master Plan for computer system validation. I got that plus more. The included documents and references were very helpful. The format of the seminar was good. I appreciated having the transcript of the seminar as a companion document.
    This seminar and the Labcompliance web site have been very helpful. I was overwhelmed, knowing that I needed to generate many documents but not knowing where or how to start. Now I can get started. Your current list is so extensive!.
    Mr. Andy Young, Celerus Diagnostics. Engineering Department, USA (Ref 1019)
  8. Audio Seminar: Computer System Validation: Step-by-Step
    Feedback: The seminar did exceed my expectations. We are preparing for our first FDA audit as our Clinical Research Department has just finished doing clinical trials for a customer who is now going to market with a new drug. Part of this will require an FDA audit of our LAB. About 60 persons in our lab representing all departments attended and all were impressed on the great amount of information that was conveyed in such a short period. The perfect overview of FDA requirements for our company, Ms. Brian Flaherty, Spectra Laboratories,  Sr Technical Writer, IT, USA (Ref T-1052).
  9. Audio Seminar: Computer System Validation: Step-by-Step
    Feedback: The seminar did exceed my expectations. The seminar provided a comprehensive discussion of Computer System Validation principles,  Thanks Ludwig..I've never been disappointed with one of your seminars. Mr. Larry Gayleard, LG Consulting Services, QA Consultant, USA (Ref T-1051).