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 110
Configuration Management and Change
Control for Software and Computer Systems
Recorded

It is well known that most problems of software, computer systems and networks
are introduced when changes are made, either during development or during use of
the systems. In adequate documentation of changes and testing after changes is
one of the most frequently cited deviations during FDA inspections. Users of the
system, system owners and network administrators are unsure on how to document
initial set-up and manage changes.
Key Questions 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
- Who can initiate and who can approve changes
- How to document 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
- 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 this 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:
- FDA and EU requirements for configuration management and
change control
- The IEEE model for change control
- Implementing changes for specifications
- The change control process for planned and unplanned changes
- Versioning of software and computer systems
- How to document changes
- What to test after changes
- Regression testing for system checks after the change
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
- Templates/Examples
- Identification of computer systems
- Identification of network infrastructure and systems
- FDA 483 inspectional observations and warning letters with
deviations related to laboratory computers
- 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
How to order
Pick one of the options in the table that fits your needs.
Replaced by the more recent seminar
Configuration Management and
Change Control for Computer Systems
Changes of Hardware, Firmware,
Software, Networks, Documentation
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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.