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
To share this seminar info with your colleagues,
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Testimonials
So far we have received very positive
feedback from attendees of Ludwig Huber's seminars on
Network and Infrastructure qualification. To
learn how
seminars and the Labcompliance Network Quality Package
helped to qualify
Networks and Infrastructure
click here.
On-line Audio Seminar 362
Qualification of Virtual Networks and
Cloud Computing
With Strategies
and Tool Kit for Compliance and System Uptime
Recorded, available with all reference material
at any time

Virtual networks and 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 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 and cloud computing
Key Questions related to Qualification of Virtual
Networks and Cloud Computing are:
- What is the difference between qualification of Virtual
Machines vs. Physical Servers?
- What are the advantages and disadvantages of virtual
networks and cloud computing in FDA regulated environment?
- Do the FDA and other agencies allow the use of virtual
networks and cloud computing?
- What are the main compliance risks for cloud storage and
computing?
- What exactly are the expectations of
inspectors for qualification?
- How to apply risk management for VM and cloud computing?
- Do we need to follow a lifecycle model for qualification?
- How to implement GMP requirements to cloud computing?
- Do the benefits of virtual networks and cloud computing
justify the additional effort to comply?
- 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
- Infrastructure qualification vs. system validation
- How to deal with major issues: security, data availability
and data integrity
- Going through a complete project for virtual network
qualification
- Specific considerations for change control
- Recommendations for different cloud versions:
internal/external private, public
- Issues with different cloud services: platform,
infrastructure and software
- Responsibilities: the importance of quality 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
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: Using Cloud Computing in
Regulated Environments
- SOP: Using the Internet in Regulated Environments
- SOP: Validation of Web-Based Applications
- SOP: Change Control for Networks and
Systems - Planned Changes
- SOP: Change Control for Networks and
Systems - Unplanned Changes
- 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
- IVT Standard: Network Infrastructure
Qualification
- Article published in Biopharm:
Qualification of Network Infrastructure and Validation of
systems
- Example and 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
- NIST Guidelines related to Cloud
Computing
- Transcript FDA Presentation: Virtualization and Cloud
Computing, (link)
- White Paper: Virtualization and Risk: Key Security
Considerations for Your Enterprise Architecture (link)
- Related laws and regulations
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.-

|
Recorded seminar -
CD
- Get the CD in your mail
- Order includes all reference material.
|
US$ 399.-

|
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.-

|
Please forward to your colleagues
just
click here
About audio seminars

Online audio seminars are
presented over the phone. During the live presentation attendees
can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a
seminar room
- 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.
- Audio Seminar:
Qualification of Virtual Networks and Cloud Computing
Feedback:
The seminar did exceed my expectations.
Excellent detail and descriptions made the content very easy to
understand. Very good information, especially around
virtualization
Ms. Christy Milner, Samumed
Regenerative Medicine, Director ,QA,
USA
(Ref T-1169).
- 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-1005).
- 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)..
- 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).