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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

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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

Replaced by the more recent seminar

IT Infrastructure and Network Qualification

Introduction and Strategies for Compliance and System Uptime

Click here

About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. 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.

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.