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10+ Best Practices Reference Documents: All included in the seminar

This documents includes examples for a test plan, test script, test traceability matrix and a test summary report.

The reference material includes links to FDA and international regulations related to computer systems. 

The handout includes examples for warning letters related to Part 11 and Laboratory Computer systems  

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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Online Audio Seminar 300

Cost Effective Validation of Laboratory Computer Systems

With industry proven examples for all validation steps

Recorded, available with all reference material at any time

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Laboratory systems are amongst key targets of FDA inspections. They are considered high risk systems because they can have a high impact on the quality of APIs and drug products. Validation can be a challenge because laboratory computers become more and more automated and complex resulting in more demand for validation. Therefore users of laboratory systems are looking for cost-effective validation solutions with examples for all validation steps.

Key Questions for Laboratory Computers are:

  • How to define a validation program for laboratory computers?
  • What are FDA, EMA, USP and GAMP® requirements?
  • What and how much to test?
  • Are vendor audits required?
  • How to define risk categories?
  • What exactly is included IQ/OQ/PQ
  • Should we test standard functions of data systems?
  • How to validate networked systems?
  • How to validate existing systems?
  • What to revalidate and document after changes?
  • How to validate laboratory computers for Part 11 compliance?
  • Are there any ready-to-use

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:

  • FDA GxP, Part 11 and EU Annex 11  requirements for laboratory computers - What do inspectors ask and what documents should be available.
  • Most frequently cited deviations related to laboratory computers.
  • Laboratory system validation according to GAMP® and USP
  • Developing a validation master plan for laboratory computers
  • Writing user requirement specifications
  • Validation steps with examples: DQ/IQ/OQ/PQ
  • Recommendations for risk based validation.
  • Validation of networked systems
  • Validation of existing systems
  • Maintaining laboratory systems in the validated state
  • Validation of integrated instrument hardware and computer systems
  • Documenting validation steps from planning to reporting with examples

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

  • PowerPoint Presentation
  • Script
  • All questions and answers from before, during and after the seminar
  • SOPs:
    - Validation of Laboratory Computer Systems
    - Risk Assessment for Laboratory Systems
    - Risk based validation of laboratory computers
    - Periodic Evaluation and Review of Computerized Systems
    - Retrospective Validation of Laboratory Computer Systems
  • Gap analysis: Laboratory computers systems
  • Templates/Examples for Chromatographic Data Systems
    - Project plan
    - Requirement Specifications
    - Risk assessment
    - Vendor qualification
    - Installation qualification
    - Operational qualification
    - Performance qualification
    - Test plan
    - Test protocols
    - Validation report
  • FDA 483 inspectional observations and warning letters with deviations related to laboratory computers
  • FDA regulations and guidelines related to computers
  • FDA Guidelines Related to 21 CFR Part 11
  • And more....

A full set of 'ready-to-use' filled in validation examples

The seminar material includes full set of filled in validation examples

Who should attend?

  • Analysts and lab managers
  • Validation specialists
  • QA managers and personnel
  • IT Managers and staff
  • Regulatory affairs
  • Training department
  • Documentation department
  • Consultants

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.

Dr. 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 explined FDA'snext 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,