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 173
IT Infrastructure and Network
Introduction and Strategies for Compliance
and System Uptime
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 legislation IT infrastructure and
network qualification and compliance become a much more recognizable issue at
higher levels of management. However currently there is no official guideline
and the situation is similar to what happened with computer validation in early
90's and with early Part 11 issues. Until there will be an industry wide
accepted approach companies either waste valuable resources because doing too
much or take a risk to fail inspections because not doing enough or doing it
wrong. With FDA's renewed focus on computer validation and IT systems, industry
is looking for advice on how to comply for networks and infrastructure.
Key Questions are:
- 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?
- How to qualify PC clients, servers and data centers?
- 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 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
During the interactive presentation you learn about:
- Laws, regulations and guidelines- 21 CFR Part 11, HIPAA,
- The FDA Industry Guide: Cybersecurity for Networked Medical
- The GAMP/ISPE Good Practices Guide
- The IVT proposed NIQ 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 special seminar website
- IVT Standard: Network Infrastructure Qualification
- SOP: Change control for planned changes
- SOP: Change Control for Unplanned Changes
- SOP: Qualification of PC Clients
- SOP: Qualification of Data Centers
- SOP: Handling Security Patches
- SOP: Testing File Integrity of E-Mail Attachments
- SOP: Using the Internet in Regulated Environments
- Gap Analysis/Worksheet: Network Infrastructure Qualification
and System Validation
SOP: Risk Based Qualification of Network Infrastructure
- SOP: Development and Maintenance of Test Scripts for
- Example: Network qualification plan
- Article published in Biopharm: Qualification of Network
Infrastructure and Validation of systems
- Example: Testing Authorized System Access
- Template: Network Infrastructure and System Identification
- 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
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
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,