Audio Seminars

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

 

 

1) Edwin Rivera: Data Integrity and Fraud – Another Looming Crisis?

2) George Smith: Update on Part 11

3) George Smith: Risk based computer system validation

The reference material includes links to FDA and international regulations and guidelines

 

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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Testimonials

So far we have received very positive feedback from attendees of Ludwig Huber's seminars on Computer System Validation. To learn how the seminar and the Labcompliance Computer System Validation package helped to validate software and computer systems, click here

On-line Audio Seminar 345

Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for easy Implementation

Recorded, available with all reference material at any time

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Validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last four years. Validation professionals know the principles but have problems with implementation, especially with the development of compliant protocols.

Specific Questions related to validation of  computer systems are:

  • What are the exact FDA requirements and what are inspectors looking for?
  • What mistakes do other companies make?
  • Which model should we follow: IQ/OQ/PQ qualification of verification?
  • Which documents do we really need?
  • How detailed should requirement specifications be?
  • Where and how to document the risk level of a computer system?
  • How to justify and document that we have selected the right vendor?
  • What information should users develop during installation?
  • What and how much to test before we can use the system?
  • Should we validate standard software functions?
  • How to document and test configuration settings?
  • What to tests and document ongoing performance?
  • How much can we rely on vendor certificates and documents?
  • Where can we get templates and example documents?
  • Are there different requirements for US FDA and Europe?
  • How can we keep validation costs under control

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 give practical recommendations. After the seminar, an extensive list of reference material like case studies, validation plans, protocols, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • US FDA and EU requirements and enforcement practices
  • Learning from recent FDA 483's and warning letters
  • Selecting the right validation model: qualification vs. verification
  • Keep validation costs under control
  • Eight fundamental steps for cost effective computer system validation
  • Structure and example of a validation plan
  • Justification and documentation of risk levels
  • Example qualification document for suppliers of commercial systems
  • Examples for requirement and functional specifications?
  • Example for IQ protocols
  • OQ test protocols: development, execution, approval - examples
  • Documentation of ongoing performance
  • Validation of existing systems
  • Structure and example of a validation report
  • Step-by-step case studies from laboratories and manufacturing for easy implementation
  • Using prepared fill-in templates and examples for cost-effective implementation
  • Most common pitfalls
  • Frequently asked questions

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

  • Slides as PowerPoint Presentation
  • Script
  • Q&As from before, during and after the seminar
  • Master Plan
    - Computer System Validation
  • SOPs:
    - Validation of Commercial Off-the-Shelf Computer Systems
    - Development and Maintenance of Test Scripts for Software and Computer Systems
  • Gap analysis/checklist:
    - Using computers in FDA regulated environments
  • Templates/examples
    - Validation master plan
    - Validation project plan
    - Risk assessment
    - Vendor assessment
    - Requirement specifications
    - Installation qualification
    - Operational qualification
    - Test Plan - Test Protocols,
    - Performance qualification
    - Validation report
  • Case Studies
    - Step-by-step Validation: Chromatography Data System
    - Step-by-step Validation: Document Management System
  • 10 recent Warning letters and Inspectional observations related to software and computer validation
  • FDA/EU Guidance documents related to software and computer validation

Who should attend?

Industry

  • Pharmaceutical development and manufacturing
  • Biopharmaceutical development and manufacturing
  • Medical device
  • Blood testing/Clinical testing

Functions

  • IT managers and system administrators
  • QA managers and personnel
  • QC and Lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • Consultants
  • Everybody using computers in FDA regulated environments
  • Everybody using computers in FDA regulated environments
  • IT manager and staff
  • QA managers and personnel
  • Quality control directors or delegates
  • Regulatory affairs
  • Training departments
  • Consultants
  • Validation specialists

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 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,

Testimonials/References

 

 

The Feedbacks on the seminar has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

  1. Audio Seminar : Learning from Recent FDA Warning Letters Related to Computer Systems and Part 11
    Feedback: The seminar did exceed my expectations. Lots of examples given which helped me understand where the focus of the inspectors lies. Excellent  seminar. Mark Elsley, Novo Nordisk, Head of Data Management Department , Sweden , Belgium (Ref T-1053)
  2. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  The seminar is very useful as it contains a lot of information.
    Mr. Lucian Hirtie,  QS Manager, Labstat International ULC, Canada
    (Ref T-1082).
  3. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  Very informative presentation, and clearly presented . Dr Huber does an excellent presentation, well developed, and very informative, as usual.
    Mr. John Egoville,  Senior Compliance Auditor,  Computer Validation Group, TEVA Pharmaceuticals, USA
    (Ref T-1081)

  4. Seminar: Recent Warning Letters and 483's Related to Computer Validation and Part 11
    Feedback:
    The seminar did exceed my expectations.  The presentation contains much more pertinent information than I had expected.
    Mr. Joachim Fehr, Stryker, CSV Specialist QA, Germany
    (Ref T-1076).
  5. Seminar: FDA's New Enforcement of 21 CFR Part 11
    Feedback:
    The seminar did meet my expectations.  I always expect a wonderful seminar from Dr. Huber, and my expectations were once again met. A great time saver for me as I do not have time to look up recent 483s relating to Part 11 -- worth the time and cost.
    Ms. Diana Mayes, Manager of ABC Laboratories, USA
    (Ref T-1077).
  6. Seminar: FDA's New Enforcement of 21 CFR Part 11
    Feedback: The seminar exceed my expectations.  Webinar was very informative to our current practice and will help us focus and stream line our process. I would recommend this seminar to everyone having the same responsibilities.
    Ms. Mike Robertson, QA Engineer at Energizer, USA
    (Ref T-1078).
  7. Seminar:  Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11
    Feedback: I basically wanted a overview of what the FDA is looking for and this webinar fit my needs exactly. I thought the presentation of the material was done very well, DR Huber is obviously knowledgeable and he presented the subject matter very clearly.
    Mr. Gene Rideout, Instrumentation laboratory, Software Quality assurance, R&D,   USA
    (Ref T-1083).