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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
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On-line Audio Seminar 305

FDA Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available with all reference material at any time

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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 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 guideline from the FDA?
  • What do inspectors ask and what do they want to see?
  • What is the approach of the GAMP5 and GAMP/ISPE Good Practices Guides?
  • What is 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 accuracy and integrity of file transmissions?
  • How to qualify PC clients, servers and data centers?
  • I have multiple clients with the same configuration, should I qualify/validate all of them?
  • How to qualify virtual networks?
  • 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 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 implementation.

During the interactive presentation you learn about:

  • Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley
  • FDA inspection/enforcement practices: examples for Warning Letters/483s
  • The FDA Industry Guide: Cybersecurity for Networks
  • The GAMP/ISPE Good Practices Guides and the IVT NIQ Standard
  • Principles and advantages of network infrastructure qualification
  • Compliance concepts for infrastructure vs. networked systems
  • Approaches and examples for risk assessment
  • Configuration management and change control: the most important steps
  • Qualification of PC clients, servers, data centers
  • What and how much to test with the risk based cost/benefits in mind
  • Handling security patches
  • Dealing with existing/legacy infrastructure
  • Considerations for network retirement
  • Qualification of virtual networks and CLOUD computing
  • How to maintain the validate state during on-going use
  • Documentation requirements
  • Going through a life inspection

And for easy and instant implementation:
download 15+ documents from special seminar website

  • Example: Network Infrastructure Qualification Plan
  • SOP: Risk Based Qualification of Network Infrastructure
  • SOP: Qualification of PC Clients
  • SOP: Qualification of Data Centers
  • SOP: Qualification of Servers
  • SOP: Handling Security Patches
  • SOP: Testing File Integrity of E-Mail Attachments
  • SOP: Using the Internet in Regulated Environments
  • SOP: Qualification of Virtual Networks
  • SOP: Change Control for Networks and Systems - Planned Changes
  • SOP: Change Control for Networks and Systems - Unplanned Changes
  • Gap Analysis/Worksheet: Network Infrastructure Qualification and System Validation
  • SOP: Development and Maintenance of Test Scripts for Equipment Hardware&Software
  • IVT Standard: Network Infrastructure Qualification
  • Article published in Biopharm: Qualification of Network Infrastructure and Validation of systems
  • Example: Testing Authorized System Access
  • Template and examples:: 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
  • Consultants
  • Teachers

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

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

Recorded seminar - Web Download

  • 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$ 399.-
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Recorded seminar - CD

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

US$ 399.-
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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$ 299.-
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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.

. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explained FDA's next steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,