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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 216

Management and Validation of Computers for ISO 17025

Requirements, Recommendations and Tools for Implementation

Recorded, Available on Demand

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Computers are widely used in chemical laboratories for instrument control, data acquisition, data evaluation, reporting document management and for archiving. ISO 17025 requires good management and control to ensure accuracy, confidentiality  and integrity of data. Because of this importance seven chapters and three appendices have one or more paragraphs related to software or computer systems. In total ISO 17025 has 33 clauses that reference to computers, either directly or indirectly. Most of them are short and need further interpretation.

Frequent questions are

  • What are the specific software and computer system requirements of ISO 17025
  • What are the minimal validation requirements?
  • What is the difference between validation, qualification and verification of software
  • How to validate networks?
  • Should we validate firmware that controls automated instruments?
  • How to demonstrate data integrity as required by ISO 17025?
  • What should we retain and archive: just paper, electronic records or both ?
  • Are there any specific software functions required by ISO 17025?
  • Are there any consideration for using Excel for data processing?
  • Can we use wireless LAN for data acquisition and transmission?
  • Can we use the public Internet to transmit analytical test results?

How does the audio seminar help:

Questions will be answered by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar strategies and procedures will be presented on how to develop, document, maintain and update User Requirements. 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:

  • Requirements of ISO 17025
  • Software clauses in ISO 17025: Identification and Interpretation
  •  Dealing with basic requirements for data: accuracy, availability, integrity, confidentiality
  • Protecting computers to ensure confidentiality and integrity of data
  • Minimal required software functions for ISO 17025
  • Required procedures for ISO 17025
  • Verification and validation steps
  • Allocation of computer systems into different categories
  • Risk assessment as a tool to optimize resources
  • Using networks and the internet in ISO 17025 environments
  • Special considerations for Excel Spreadsheets
  • Signing records electronically
  • Archiving of electronic data: what, how, which format?

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

  • SOPs:
    - Using Software and Computer Systems for ISO 17025
    - Validation of Computer Systems used in ISO 17025 Environments
    - Auditing Computer Systems
    - Change Control of Software and Computer Systems
    - Retention and Archiving of Electronic Records
    - Validation of Excel Spreadsheet Applications
    - Access Control to Computer Systems and Data
  • Gap analysis/checklists:
    - Using Computer Systems in ISO 17025 Environments
  • Quality Reference Document: 33 Computer and Software Clauses in ISO 17025
  • Templates/examples
    - Requirement Specifications for Chromatographic Data Systems
    - Validation Plan for a Chromatographic Data System
    - Documenting Installation of Networked Computer Systems
    - Requirement Specifications for Excel Spreadsheets
    - Test protocol
    - Summary report

Who should attend?

  • System owners
  • Software developers
  • IT managers and system administrators
  • QA managers and personnel
  • All users of software and computer systems in regulated environments
  • Validation professionals
  • Training departments
  • Documentation department
  • Consultants

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

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 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.