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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.

On-line Audio Seminar 177

FDA's New Guide on Using Computerized Systems in Clinical Investigations

Understanding FDA's New Approach Towards Computer Systems


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The FDA just released the new guidance on using computers in clinical trials. This document replaces the guidance of the same name dated April 1999 and the more recent draft guidance from 2004 . The content of the new guidance is is significantly different from the previous ones. It reflects FDA's new approach towards computer systems and electronic records and it is expected to have a high impact on all FDA regulated areas, not only on clinical trials. The guide is shorter than the previous ones, and in many areas it is less specific but requires a lot of interpretation. So the industry is more unsure than ever on what to do.

Key Questions are:

  • What is the difference between the new and previous guidances?
  • Which systems should comply with the new guidance?
  • What and how much to test for electronic data capture systems?
  • In which format should we archive computer generated study data?
  • We plan to send study results over the public internet. What controls should be in place?
  • How can we document and defend 'integrity' of electronic study data?
  • What does it mean: The system should not allow an individual to log on to the system to provide an other person access to the system?
  • What are the requirements for source documents or source data and supporting data?
  • The guide suggests to 'identify' each step at which computers are used to create, modify, archive, retrieve, or transmit source data. How should identification look like?
  • How to deal with legacy systems?
  • What levels of details are required to 'fully' reconstruct a study?
  • What are the exact requirements for contingency planning, back-up and disaster recovery?

How does the this audio seminar help:

The seminar will be presented by Dr.Ludwig Huber. During the seminar, the speaker will present detailed information on the guidance and give practical recommendations and examples. 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's new thinking on how to deal with computer systems
  • Recent FDA warning letters related to computer systems
  • Major differences between the new and the older guidances
  • Responsibilities of sponsor and contract labs
  • Internal and external security requirements
  • Requirements for audit trails
  • Requirements for data entry, archiving and retrieval
  • Risk based change controls: software upgrades, patches
  • Storage and backup of data, contingency planning
  • Risk based validation and other controls
  • Using the internet to report clinical study results
  • Strategies for compliance implementation

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

  • Checklist: Using Computers for Clinical Trials
  • Regulatory Reference Document: Requirements for Clinical Study Records
  • SOP: Roles and Responsibilities of Sponsors, Clinical Sites and Other Parties for Computerized Systems
  • SOP: Risk assessment for GxP Environments
  • SOP: Data Back-up and Restore
  • SOP: Recording of GCP Source Data
  • SOP: Archiving and Retrieval of GCP Study Data and Other Documents
  • SOP: Disaster Recovery for Computer Systems
  • SOP: Access Control to Computer Systems and Data
  • SOP: Training for GxP, 21 CFR Part 11 and Computer Validation
  • Computer system validation master plan: 53 pages
  • Template and examples: Computer System Identification
  • FDA Presentation: The Facts About (Clinical Study) Source Documents
  • FDA Presentation: The Role of the Investigator in Clinical Research
  • FDA Presentation: What the Investigator and Sponsor Need to Know
  • FDA guidance: Computerized Systems Used in Clinical Investigations
  • Recent FDA Warning Letters related to software and computer systems
    More ....

Who should attend?

  • (Bio)pharmaceutical and medical device industry
  • Sponsors and (clinical) contract labs
  • System owners
  • Validation specialists
  • IT specialists
  • QA managers and personnel
  • Software developers
  • Users of software and computer systems
  • Regulatory affairs
  • Training department
  • Documentation department
  • Consultants

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.