Audio Seminars

Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars

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 101

Strategies for Cost Effective Network Compliance and System Uptime

Recorded

Order Button

In a recent FDA/ISPE seminar FDA's national expert George Smith, a member of FDA's part 11 task force, said in a Q&A session: "Networks used in GMP environment should be validated (qualified?)". The questions is: how? Considering the size of some networks and the many changes occurring this can be a huge effort and expensive.

Questions are:

  • What do inspectors ask and what do they want to see?
  • We validate the application running on the network, so we know that it works, why should we validate the network?
  • Should we test each network component, like switches, routers and servers?
  • How to verify accuracy of network 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?
  • Our network changes so often, how can I keep it in a validated state?
  • How can I increase system uptime with network qualification?

How does the audio seminar help:

Questions will be answered by Dr. Ludwig Huber in a new interactive audio seminar. The focus during the seminar will be on optimizing costs and still meet FDA requirements using a risk based approach. Attendees will get detailed step by step instructions on how to qualify network infrastructure and validate systems. 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:

  • FDA and EU requirements for network infrastructure and systems - What do inspectors asks and what documents should be available
  • The best compliance concepts for the infrastructure and networked systems
  • Configuration management and change control as the most important network qualification steps
  • What and how much to test with the risk based cost/benefit in mind: network components, servers, PC clients, applications, initial vs. on-going testing
  • How to ensure highest system uptime with on-line monitoring tools

And for easy and instant implementation:
download 10+ documents from password protected website

  • SOPs: Change control for planned and unplanned changes, access to networks, verification of data file accuracy, GxP and Part11 training
  • Gap analysis for infrastructure and networked systems
  • Network qualification project schedule
  • Article published in Biopharm: Validation of network infrastructure and validation of systems
  • IVT Proposed Standard: Network Infrastructure Qualification
  • Five page FDA inspectional inspectional observation and several warning letters with deviations related to network infrastructure
  • And more....

Who should attend?

  • QA managers and personnel
  • IT managers and personnel
  • Production and lab managers
  • 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.