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 125

Network Infrastructure Qualification

Introduction and Strategies for Compliance and System Uptime

Recorded

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. However currently there is no official guideline and the situation is similar to what happened with computer validation in early 90's and with general part 11 issues from 2000 to2003. 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.

Questions are:

What does network compliance mean?
Is there an official standard from an agency or industry?
What do inspectors ask and what do they want to see?
Should networks comply with 21 CFR Part 11?
What about other legislation such as Sarbanes-Oxley and HIPAA?
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 validated state?

How does the audio seminar help:

Questions will be answered by Dr. Ludwig Huber in a new interactive audio seminar. After an introduction the seminar will focus on economic strategies and step by step instruction for regulatory compliance. During the seminar attendees will get detailed step by step instructions on how to qualify network infrastructure. An extensive list of reference material like SOPs, templates an, examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

Laws, regulations and guidelines
- 21 CFR Part 11, HIPAA, Sarbanes-Oxley
Industry guidelines, standards, and expert advice
Principles of network infrastructure
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 tools
Documentation requirements
Going through a life inspection
Software tools for infrastructure qualification

And for easy and instant implementation:
download 10+ documents from dedicated seminar website

IVT Standard: Network Infrastructure Qualification
SOP: Change control for planned changes
SOP: Change Control for Unplanned Changes
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: Validation of Commercial Off-the-Shelf Computer Systems
Example: Network qualification project schedule
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
And more...

Who should attend?

QA managers and personnel
IT managers and personnel
Auditors
Production and lab managers
Users of networks
Validation specialists
Consultants
Teachers

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web download 'Site' offer

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.

US$ 349.-

Recorded seminar - CD

Get the CD in your mail
Order includes all reference material.

US$ 349.-

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$ 249.-

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 author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.

Audio Seminars