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All documents shown here are included in the seminar for instant download

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 reference material includes examples of FDA Warning Letters with citations related to analytical instrument qualification and laboratory computer system validation.

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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On-line Audio Seminar 321

Integrated Analytical Equipment Qualification and System Validation for FDA Compliance

Combining the USP <1058> with the new GAMP(TM)  Laboratory Computer Systems Guide

Recorded, available with all reference material at any time

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Analytical laboratory equipment and computer systems are amongst key targets of FDA inspections. They are considered high risk systems because they can have a high impact on product quality. Validation can be a challenge because laboratory instruments become more and more complex and automated. In the past there was no specific guidance on how to combine analytical instrument qualification with system validation. This has changed. The USP Chapter <1058> on "Analytical Instrument Qualification" is focused on equipment qualification and the new GAMP/ISPE Good Practice Guide "Risk based Approach to GxP Compliant Laboratory Computerized System" is more focused on automated systems. Both USP and GAMP/ISPE are important FDA references but unfortunately the concepts are different. So the question is: how to integrate?

Key Questions related to integrated analytical instruments and  laboratory systems are:

  • What are FDA and international requirements for analytical instrument qualification and laboratory computer system validation?
  • What are the approaches of the USP and GAMP for automated laboratories?
  • What are similarities and what are differences?
  • What is the regulatory impact of both guids?
  • Which one should we follow: the USP 4Q life-cycle model of the GAMP combined integration/system development model?
  • Is there a practical model, that can accommodate both?
  • There is a lot of discussion about qualification vs. verification: what to do?
  • What are the industry recommendations and practices for new and existing systems?
  • Can we conduct  equipment qualification by ourselves or should must vendor do it?
  • If we do it by ourselves do we need to get trained from the vendor?
  • If the equipment is repaired during warrantee period who pays for requalification: the vendor or the user firm?
  • What do the guides say about risk based testing abd how to implement?
  • What exactly are the defined instrument and system categories and what should we test and document for each category?
  • We have heard that there was a proposal for an updated more complex USP <1058>, what is the status?

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 on how to effectively comply with both. 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 and EU requirements for analytical automated laboratory systems - What do inspectors ask and what documents should be available.
  • Most frequently cited deviations related to laboratory equipment and computers.
  • The role of GAMP(TM) and USP for the FDA and international agencies
  • Getting clarification of on the terminology: what to verify, qualify and validate
  • The approach of both guides
  • Similarities and differences of both guides
  • Presenting a model that accommodates both
  • Easy identification of high, medium and low risk instruments and systems
  • Reducing validation efforts through leveraging vendor documentation
  • Savings through risk based testing
  • The anticipated future of both guides
  • Case studies: recommendations for 3 systems in different categories
    - life cycle deliverables
    - vendor assessment
    - testing before and during operation
    - documentation requirements and 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:
    - Integrated Analytical Equipment Qualification and System Validation
    - Analytical Instrument Qualification for USP <1058>
    - Validation of Laboratory Computer Systems
    - Risk Assessment for Laboratory Systems
  • Gap analysis: Laboratory computers systems
  • Case Study Integrated Analytical Equipment Qualification and System Validation - Computerized HPLC System Step-by-Step
  • Templates/Examples for Chromatographic Data Systems
    - Project plan
    - Requirement Specifications
    - Risk assessment
    - Vendor qualification
    - Installation qualification
    - Operational qualification
    - Performance qualification
    - Test plan
    - Validation report
  • FDA 483 inspectional observations and warning letters with deviations related to laboratory equipment and computerized systems
  • FDA regulations and guidelines related to computers
  • And more...

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

The seminar material includes a full set of 'FDA Friendly' validation examples

Who should attend?

  • Analysts and lab managers
  • Validation specialists
  • IT managers and staff
  • QA managers and personnel
  • QCU directors and Qualified persons
  • 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

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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.

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 explained FDA's next 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,