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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 119

Eight Steps for Cost-effective Software and Computer System Validation

Get 10 most important documents for free: SOPs, Checklists, Validation protocols


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While validating processes and equipment is well understood by people in the regulated industries software still confuses people, despite of a 20 year history and availability of guidance from industry and the FDA. The result is an increasing number of FDA 483 form inspectional observations and warning letters in this area.

Key Questions related to software and computer validation are:

  • How to develop a computer validation master plan?
  • What is the level of detail of user requirement and functional specifications?
  • How to qualify the supplier: when is a vendor audit a must?
  • What and how much to test at installation?
  • I have multiple installations with the same configurations, should I test all of them or is one enough?
  • How to document functional testing - when do I need to make screen captures?
  • How to initiate and document changes to my computer system?
  • How to validate networks and Excel?
  • How to validate existing (legacy) systems?

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 go through all validation phases 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:

  • Software and computer system validation requirements in US and EU
  • Inspection practices and findings: examples of FDA inspection reports, 483's, warning letters
  • Validation planning
  • Writing user requirements and functional and specifications
  • Validation during development or qualification of the vendor
  • Qualification phases: IQ, OQ, PQ
  • Testing: traceability marix, levels of details, documentation
  • Change control: what and how to revalidate after changes
  • Validation of existing/legacy systems
  • Most frequently asked questions (and answers): e.g-, Excel, Networks
  • Documentation

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs:
    - Validation of Commercial Off-the-Shelf Computer Systems
    - Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems
    - Risk Based Validation of Software and Computer Systems
    - Training for GxP, 21 CFR Part 11 and Computer Validation
    - Change Control of Software and Computer systems
    - Validation Of Macro Programs and other Application Software
    - Validation of Laboratory Computer Systems
    - Auditing Computer Systems
  • Gap analysis/checklists:
    - Using computers in FDA regulated environments
    - Software/Computer system vendor qualification
  • Templates/examples
    - Complete Validation example - MD5 software: DQ/IQ/OQ/PQ
    - Testing - Traceability Matrix, Test Protocols, Summary report (29 pages)
    - Computer System Identification
  • Warning letters and Inspectional observations related to software and computer validation
  • FDA/EU Guidance documents related to software and computer validation

Who should attend?

  • QA managers and personnel
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • All users of computer systems
  • Training departments
  • Documentation department
  • Consultants

How to order

Replaced by the more recent seminar

Cost Effective Software and Computer System Validation

Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5

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.