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 145

Network Infrastructure Qualification

Understanding the New GAMP/ISPE and FDA Guides

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. 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 Guide?
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 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:

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.

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 Devices
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 tools
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 Devices
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