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
On-line Audio Seminar 145
Network Infrastructure Qualification
Understanding the New GAMP/ISPE and FDA
Federal laws and regulations mandate to put controls and measures on a company
network to ensure security and data integrity. Examples are 21 CFR Part 11,
Sarbanes-Oxley Act, and HIPAA. With this new legislation network qualification
and compliance become a much more recognizable issue at higher levels of
management. This was recognized by the FDA and industry organization and
institutes such as GAMP/ISPE and the Institute of Validation and Technology
(IVT). The FDA published a guide on Cybersecurity for Networked Medical Devices,
GAMP/ISPE released a Good Practices Guide on IT Infrastructure Control and
Compliance and IVT proposed a standard for Network Infrastructure Qualification.
With FDA's new focus on computer validation and IT systems, industry is looking
for advice on how to implement the guides.
Questions related to network qualification:
- What does network compliance mean?
- Is there an official guidelines from the FDA?
- What do inspectors ask and what do they want to see?
- What does the approach of the GAMP/ISPE Good Practices
- What does the approach of the IVT proposed standard?
- Should networks comply with 21 CFR Part 11?
- What about other legislation such as Sarbanes-Oxley and
- We validate the application running on the network, so we
know that it works, why should we qualify the infrastructure?
- How much testing is enough: should we test each network
component, like switches, routers and servers?
- How to verify integrity of file 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?
- How to deal with security patches?
- Our network changes so often, how can I keep it in a
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
During the interactive presentation you learn about:
- Laws, regulations and guidelines
- 21 CFR Part 11, HIPAA, Sarbanes-Oxley
- The FDA Industry Guide: Cybersecurity for Networked Medical
- The GAMP/ISPE Good Practices Guide
- The IVT proposed standard
- Principles of network infrastructure qualification
- Compliance concepts for infrastructure vs. networked systems
- Configuration management and change control as the most
important network qualification steps
- Qualification of PC clients, servers, data centers
- What and how much to test with the risk based cost/benefits
in mind: network components, servers, PC clients, applications,
initial vs. on-going testing
- How to ensure highest system uptime with on-line monitoring
- Documentation requirements
- Going through a life inspection
- Software tools for infrastructure qualification
And for easy and instant implementation:
download 15+ documents from dedicated seminar website
- Network Qualification Plan
- IVT Standard: Network Infrastructure Qualification
- SOP: Change control for planned changes
- SOP: Change Control for Unplanned Changes
- SOP: Handling Security Patches
- SOP: Qualification of PC Clients
- SOP: Qualification of Data Centers
- SOP: Testing File Accuracy of E-Mail Attachments
- Gap Analysis/Worksheet: Network Infrastructure Qualification
and System Validation
- SOP: Risk Based Qualification of Network Infrastructure
- Example: Network Infrastructure and System Identification
- Article published in Biopharm: Qualification of Network
Infrastructure and Validation of systems
- Example: Testing Authorized System Access
- Template: Network Infrastructure and System Identification
- FDA Industry Guide: Cybersecurity for Networked Medical
- FDA Inspection Report: Five page FDA inspectional
inspectional observation and several warning letters with
deviations related to network infrastructure
- NIST Guidelines related to IT Security
- Related laws and regulations
- And more...
Who should attend?
- QA managers and personnel
- IT managers and personnel
- Production and lab managers
- Users of networks
- Validation specialists
How to order
Replaced by the more recent seminar
Infrastructure and Network Qualification
Strategies for Compliance and System Uptime
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
||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,