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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 Network Qualification. To learn how the seminar and the Labcompliance Network Qualification package helped to qualify IT infrastructure and networks, click here.

 

On-line Audio Seminar 294

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available with all reference material at any time

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Virtual networks can significantly reduce investment and operating costs for IT operations. However when used in FDA and other regulated environments they need to be qualified 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.

Key Questions related to Qualification of Virtual Networks are:

  • Why to Qualify the Network, when we Validate the Application
  • What is the difference between qualification of Virtual Machines vs. Physical Servers?
  • What are the advantages and disadvantages of virtual networks in FDA regulated environment?
  • Do the FDA and other agencies allow the use of virtual networks?
  • What exactly are the expectations of inspectors for qualification of virtual networks?
  • How to apply risk management for VM ?
  • Do we need to follow a lifecycle model for qualification?
  • Do the  benefits  of virtual networks justify the additional effort to comply?
  • How to document the use virtual networks 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
  • Possible issues when used in FDA regulated environments
  • Recommendations from official task forces
  • Infrastructure qualification vs. system validation
  • Key applications
  • Virtualization of computers, servers and systems
  • How to deal with major issues: security, data availability and data integrity
  • Going through a complete project for virtual network qualification
  • Qualification of hardware, software and virtual machines
  • Deployment modes
  • Specific considerations for change control
  • Potential virtualization risks
  • Qualification of virtual networks used for cloud computing
  • Putting everything together: documentation for the FDA and every other agency

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

  • SOP: Risk Based Qualification of Network Infrastructure
  • SOP: Qualification of Virtual Networks
  • SOP: Change Control for Networks and Systems - Planned Changes
  • SOP: Change Control for Networks and Systems - Unplanned Changes
  • SOP: Handling Security Patches
  • SOP: Development and Maintenance of Test Scripts for Equipment Hardware&Software
  • Example: Network Infrastructure Qualification Plan
  • Gap Analysis/Worksheet: Network Infrastructure Qualification and System Validation
  • Article published in Biopharm: Qualification of Network Infrastructure and Validation of systems
  • Example: Testing Authorized System Access
  • Template and examples: Network Infrastructure and System Identification
  • FDA Inspection Report: Five page FDA inspectional inspectional observation and several warning letters with deviations related to network infrastructure
  • Transcript FDA Presentation: Virtualization and Cloud Computing, (link)
  • White Paper: Virtualization and Risk - Key Security Considerations for Your Enterprise Architecture (link)
  • Related regulations and Guidelines

The figure below shows a comparison of accuracy data obtained with new USP procedures <233> vs. the existing <231>. Attend the Labcompliance seminar to learn more about different modern equipment as recommend by USP.  ICH draft Q3D simply refers to Pharmacopeia procedures.

 

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

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.

Dr. 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 explined FDA'snext 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).