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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 145

Network Infrastructure Qualification

Understanding the New GAMP/ISPE and FDA Guides

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. 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

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.