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.
On-line Audio Seminar 101
Strategies for Cost Effective Network
Compliance and System Uptime
Recorded
In a recent FDA/ISPE seminar FDA's national expert George Smith, a member of
FDA's part 11 task force, said in a Q&A session: "Networks used in GMP
environment should be validated (qualified?)". The questions is: how?
Considering the size of some networks and the many changes occurring this can be
a huge effort and expensive.
Questions are:
- What do inspectors ask and what do they want to see?
- We validate the application running on the network, so we
know that it works, why should we validate the network?
- Should we test each network component, like switches,
routers and servers?
- How to verify accuracy of network transmission?
- I have multiple clients with the same configuration, should
I qualify/validate all of them?
- We have an existing network, where and how should we start?
- Our network changes so often, how can I keep it in a
validated state?
- How can I increase system uptime with network qualification?
How does the audio seminar help:
Questions will be answered by Dr. Ludwig Huber in a new
interactive audio seminar. The focus during the seminar will be on
optimizing costs and still meet FDA requirements using a risk based
approach. Attendees will get detailed step by step instructions on
how to qualify network infrastructure and validate systems. 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:
- FDA and EU requirements for network infrastructure and
systems - What do inspectors asks and what documents should be
available
- The best compliance concepts for the infrastructure and
networked systems
- Configuration management and change control as the most
important network qualification steps
- What and how much to test with the risk based cost/benefit
in mind: network components, servers, PC clients, applications,
initial vs. on-going testing
- How to ensure highest system uptime with on-line monitoring
tools
And for easy and instant implementation:
download 10+ documents from password protected website
- SOPs: Change control for planned and unplanned changes,
access to networks, verification of data file accuracy, GxP and
Part11 training
- Gap analysis for infrastructure and networked systems
- Network qualification project schedule
- Article published in Biopharm: Validation of network
infrastructure and validation of systems
- IVT Proposed Standard: Network Infrastructure Qualification
- Five page FDA inspectional inspectional observation and
several warning letters with deviations related to network
infrastructure
- And more....
Who should attend?
- QA managers and personnel
- IT managers and personnel
- Production and lab managers
- Validation specialists
- Consultants
- Teachers
How to order
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Replaced by the more recent seminar
IT Infrastructure and
Network Qualification
Introduction and
Strategies for Compliance and System Uptime
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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.
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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.