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

Recorded

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 This document replaces the guidance of the same name dated April 1999 and the more recent draft guidance from 2004 .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 'Site' offer

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$ 349.-

Recorded seminar - CD

Get the CD in your mail
Order includes all reference material.

US$ 349.-

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$ 249.-

About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

Study the printed slide material
Watch the slides on a computer
Watch the slides on a video screen in a seminar room
Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.

Audio Seminars