Labcompliance On-line Audio Seminar
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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
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On-line Audio Seminar 291
Configuration Management and Change
Control for Networks and Computer Systems
Changes of Hardware, Firmware, Software,
Networks, Documentation
Recorded, available with all reference material
at any time

It is well known that most problems of software, computer systems and networks
are introduced when changes are made, either during design and development or
during use of the systems. Too many changes of computer systems and inadequate
documentation of changes and testing after changes is one of the most frequently
cited deviations during FDA inspections. Users of the systems, system owners and
network administrators are unsure on how to document initial set-up and manage
changes.
Key Questions for change control are
- What is the difference between configuration management and
change control
- How to document the configuration baseline
- How detailed should networks be documented - e.g., cables
- How to avoid frequent changes
- How to initiate and authorize changes
- What and how much to test after the change
- How to develop SOPs and forms for change requests, release
and tracking
- How to manage unplanned changes, e.g., hot fixes, security
patches
- How to deal with service packs and patches
- How to deal with changes made by vendors and 3rd parties
- How to deal with changing user requirements during software
development?
- The FDA recommends regression testing after software changes
- what does this mean in practice
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 give practical recommendations. After the
seminar, an extensive list of reference material like SOPs,
templates and examples will help immediate and cost effective
implementation. Attendees will learn how to avoid problems through
application of proven industry practices for configuration
management and change control.
During the interactive presentation you learn about:
- US FDA and EU requirements for change control
- Defining configuration management vs. change control and
change management
- The GAMP IEEE models for configuration management and change
control
- How to avoid frequent changes of a computer system
- Reviewing a change control procedure
- Change control for hardware, operating systems and
application software
- The change control process for planned and unplanned changes
- Dealing with security patches
- Versioning of software and computer systems
- What to test after changes
- How to document changes
- Going through examples
- - hardware
- firmware
- software (operating system, applications, security patches)
- networks (server, client, router)
- documentation (specifications)
And for easy and instant implementation:
download 10+ documents from special seminar website
- SOPs:
- Change control of software and computer systems
- Change control of networks - planned changes
- Change control of networks - unplanned changes
- Handling security patches
- Configuration management and version control of software
- Templates/Examples
- Identification of computer systems (Baseline Configuration)
- Identification of network infrastructure and systems
(Baseline Configuration)
- Six case studies
- Master plan
Computer System Validation (53 pages)
- Reference paper:
Risk based validation of Commercial Off-the-shelf Computer
Systems
- FDA 483 inspectional observations and warning letters with
deviations related to software, computer systems and change
control
- FDA regulations and guidelines related to computer
validation
- And more....
Additional benefit: Receive six case studies
Case studies include typical planned and unplanned
changes from production control, laboratory controls and
documentation. They include planned and unplanned changes of
specifications, hardware, firmware, operating software, application
software and MS security patches.
Who should attend?
- Validation specialists
- QA managers and personnel
- Regulatory affairs
- IT department
- Training department
- Documentation department
- Consultants
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.
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US$ 399.-

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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.-

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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.
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, |