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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 for the presenter's Part 11 seminars

On-line Audio Seminar 344

Learning from Recent Warning Letters related to Part 11 and Computer Validation

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available with all reference material at any time

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Some time ago FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of many inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings and inspectors regularly cited deviations related computer validation and other Part 11 issues. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. Because of missing clear guidance the industry has lots of questions

Key Questions related to Warning Letters, Computer Validation and Part 11 are:

  • What is FDA's most current thinking related to computers and electronic records?
  • What are the inspection trends?
  • What are most frequent recent citations related to electronic records?
  • What are the most frequent deviations for computer system validation?
  • Under which circumstances can inspectors exercise enforcement discretion?
  • How important is risk based Part11 compliance?
  • When and how to best respond to 483's to avoid warning letters?
  • Why do most responses to 483's and Warning Letters fail?
  • What is the best strategy for future proven Part 11 compliance?
  • Are there proven tools that help to implement strategies?

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 examples and recommendations on how to avoid Part 11 related FDA warning letters and 483's. After the seminar, an extensive list of reference material like case studies on how to avoid or respond to 483's,  SOPs, checklists and templates will help immediate and cost effective implementation of a Part 11 program that is in line with current and future FDA's expectations. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn about:

  • FDA inspections: Preparation, conducts, follow up
  • The meaning of warning letters and 483 inspectional observations
  • Learning from an FDA presentation: “Data Integrity and Fraud - Another Looming Crisis?”
  • Data integrity and authenticity: FDA's new focus during inspections
  • Examples of recent Part 11 related 483’s and Warning Letters
  • Examples of recent 483’ and warning letters related to computer system validation ‘
  • Most obvious reasons for deviations
  • Responding to 483's to avoid warning letters: going through case studies
  • Writing corrective AND preventive action plans as follow up to 483's
  • Using internal audits to prepare yourself for Part 11 related FDA inspections
  • Strategies and tools for compliant Part 11 implementation
  • The future of Part 11and computer system validation

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

  • Six example SOPs:
    - FDA Inspections: Preparation, conduct, follow up
    - Integrity and Security of Electronic Data
    - Electronic Audit trail: Specifications, Implementation, Validation
    - Review of Electronic Audit Trail
    - Auditing Computer Systems
    - Recording of GMP Raw Data
    - Archiving and Retrieval of GMP Data and Other Documents
    - Validation of Commercial Off-the-shelf Computer Systems
  • Checklists:
    - Part 11 compliance
    Security and Integrity of Electronic Data
    - Checklist: Electronic Audit Trail
  • Case Studies
    - How to avoid Part 11 related 483's and Warning Letters
    - How to respond to Part 11 related 483's and Warning Letters
  • Warning letters and Inspectional observations with typical deviations related to computer validation and Part 11 compliance
  • Publications
    -:Risk based validation of software and computer systems
  • FDA Presentations:
    - Edwin Rivera: Data Integrity and Fraud - Another Looming Crisis?
    - Steve Wilson: FDA Regulatory Perspective on Data Integrity

Who should attend?

  • 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,







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
    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).