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 173

IT Infrastructure and Network Qualification

Introduction and Strategies for Compliance and System Uptime

August 9, 2007

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 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?
• How to qualify PC clients, servers and data centers?
• 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 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
• The FDA Industry Guide: Cybersecurity for Networked Medical Devices
• The GAMP/ISPE Good Practices Guide
• The IVT proposed NIQ 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 special seminar website

• IVT Standard: Network Infrastructure Qualification
• SOP: Change control for planned changes
• SOP: Change Control for Unplanned Changes
• SOP: Qualification of PC Clients
• SOP: Qualification of Data Centers
• 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: Development and Maintenance of Test Scripts for Equipment Hardware&Software
• Example: Network qualification plan
• 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

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

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:

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 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.