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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.

On-line Audio Seminar 193

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11

With Clear Recommendations for Corrective and Preventive Actions


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David Horowitz from the FDA made it very clear: There will be fewer warning letters but they speak louder. All FDA warning letters now have to be approved by FDA management. They do not express the opinion of single inspectors but FDA's current thinking. They are much more up-to-date than regulations and FDA guidelines. The new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just in 2007/2008, there have been about 20 deviations related to computer system validation and Part 11 compliance, some with disastrous consequences for inspected companies.

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?
  • How to best avoid warning letters
  • What are most frequent citations for Part11
  • What are the most frequent deviations for computer system validation?
  • How important is risk based computer validation?
  • How to best respond to 483's to avoid warning letters?
  • How to respond to warning letters?
  • Where can I get 483's and establishment inspection reports (EIRs)

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 FDA warning letters and 483's. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and more examples will help immediate and cost effective implementation or preventive actions. 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: FDA's new focus during inspections of computer systems and e-records
  • Examples of recent Part11 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
  • Writing corrective and preventive action plans to avoid 483
  • 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
    - 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
    - Validation of Spreadsheet Applications
  • Checklists:
    - Part 11 compliance
    - Using computers in FDA regulated environments
    - Record retention and archiving of electronic records
  • 15 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
    - 21 Part 11: Past, Present and Future
  • FDA Presentations:
    - Edwin Rivera: Data Integrity and Fraud - Another Looming Crisis?
    - George Smith: Update on Part 11
    - George Smith: Risk based computer system validation
    - 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
  • Regulatory affairs
  • Training departments
  • Consultants
  • Validation specialists

How to order

Replaced by the more recent seminar

Recent Warning Letters and 483's Related to Computer Validation and Part 11

With Case Studies to Avoid and Respond to 483's and Warning Letters

Click here

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.