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
cloud computing in regulated environments.
To learn how this
seminar
helped using cloud computing in FDA&EU regulated
environments,
click here..
On-line Audio Seminar 351
Validation and Use of Cloud Computing in
FDA&EU Regulated Environments
Comply with GXPs, Part 11, EU Annex 11 and
other regulations
Recorded, available with all reference material
at any time

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 and computer systems this is not the case for
virtual networks and cloud computing
Key Questions related to Validation and Use 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.-

|
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.
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 for Ludwig Huber's Seminars on
Cloud Computing
The Feedbacks on Ludwig Huber's
seminars and validation packages have been
received by e-mails. Below please find testimonial for
previous seminars on cloud computing.
Labcompliance has permission to use the testimonials as
references. Original e-mails are stored in the Labcompliance
archive.
- Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did exceed my expectations. Content
was solid and associated materials are very helpful. The presentation
covered a broad range of relevant topics.
Dr. Huber certainly knows his subject.
Dr. Teri Stokes,
GXP International, Director, USA
(Ref T-1168).
- Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did meet my
expectations. Excellent overview and touched on the many esoteric issues
that need to be considered. Generally well done
(excellent organization, pacing).
Mr. Mr. Don Hurd, The
Realtime Group, VP Quality, USA
(Ref T-1161).
- Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
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. Jeff Wiser, Independant consultant,
USA
(Ref T-1159).
- Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did exceed my expectations. The NIST
definitions were new to me and were helpful in providing technical
understanding. Seminar contained the information that I
was looking for and more.
Ms. Monika Roschlaub, Invensys
Regulatory Compliance, Principal Consultant,USA
(Ref T-1145).
- Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did exceed my expectations. The
presenter knew the topic very well, didn't just repeat what was on the
slides. The flow of the presentation was excellent. Nice technical
overview with smooth transition to regulatory requirements.
Great seminar. I look forward to attending another one in the near
future.
Mr. David Fraser, 3M, QA Department,
USA
(Ref T-1141).
- Audio Seminar:
Validation and Use of Cloud Computing in FDA Regulated Environments
Feedback:
The seminar did exceed my expectations. Very
straight forward responses with Yes or No answers to qestions.
This may have been the best use of a training hour that I had in several
years..
Jerome Sauve, GE Healthcare, IT Compliance,
USA
(Ref T-1140).