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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
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On-line Audio Seminar 264

Auditing Computer Systems for Part 11 and Annex 11 Compliance

Prepare your organization for upcoming FDA and EU inspections

Recorded, available with the reference material at any time

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With new documents and requirements in place the focus of both FDA and EU inspections will shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic evaluation, vendor agreements,  incident management and structured back-up. Even though Part 11 is more narrow FDA started to look into issues not regulated by Part 11 such as change control, back-up and contingency planning. For example, just in the last three years more than 30 warning letters mentioned violations for computer systems, some of them with disastrous consequences for the companies. Most companies have a computer validation and Part11 compliance program in place, but either it is wrongly designed, not implemented or not followed. However, there are many questions related to auditing computers systems.

Key Questions related to auditing computer systems are:


  • What is FDA's and EU's inspections approach for computer systems?
  • What are the major differences we should pay attention to?
  • What are inspectors looking at?
  • What are the most frequently found deviations?
  • How far into the history can audits go?
  • How to develop an efficient and compliant auditing program?
  • How to prepare staff for internal and external audits of computer systems?
  • Which type of records should be available: computer print-outs, electronic records
  • What are the most burning audit questions related to NEW Annex 11
  • What are the most burning audit questions related FDA's Part 11 inspection program
  • How should I document auditing results - level of detail, summary?
  • What is the frequency of audits?
  • How to proof data integrity?
  • Can FDA inspectors asks for the internal audit reports?

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. 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 regulations and guidelines
  • 10 most frequently found deviations and how to avoid them
  • Developing an SOP for audits of computer systems.
  • Effective development and use of audit checklists
  • Assigning audit responsibilities
  • Conducting the audit: : review procedures, walk through the computer system area
  • Most critical computer system questions to ask: traditional and new ones
  • Auditing for data integrity
  • Documenting detailed audit findings
  • The audit summary report
  • Auditing for specific new Annex 11 requirements
  • Auditing in preparation for FDA's new Part 11 initiative
  • Effective follow up
  • Presenting evidence of the audit to the FDA
  • Case study: going through a life audit

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

  • SOPs:
    - Auditing Computer Systems
    - Validation of Commercial off-the-Shelf Computer Systems
    - Gap Analysis for Computer Systems
  • Examples
    - List with Required Procedures for Computer Validation
    - List with Required Records for Computer Validation
  • Checklist:
    - Using computers in regulated environments
    - Part 11 checklist
    - Annex 11 checklist (2011 version)
  • Form: Documenting audit findings
  • FDA Compliance Policy Guide: FDA Access to Results of Quality Assurance Program Audits and Inspections
  •  "Ready for a Computerized System Validation Audit",
    David Bergeson, former FDA expert for computer validation
  • FDA and other guidelines related to computer system validation and audits
  • 20 Warning letters and Inspectional observations related to computers.
    All from the last three years.
  • Five Pages PIC/S Regulatory Checklist for Inspectors: Using Computers
  • FDA Presentations
    -  Edwin Rivera: Data Integrity and Fraud - Another Looming Crisis?
    - George Smith: Risk based computer system validation

Who should attend?

  • IT managers and staff
  • QA managers and personnel
  • Operations managers
  • Users of computer systems in regulated areas
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

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

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,

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.