home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops  
 

FDA Inspections of Clinical Data Systems

 
  March 14, 2011  
     
 
The Center for Professional Innovation & Education, Dublin, Ireland
June 1 & 2, 2011


Who Should Attend

This course is designed for Quality, Data Management and IT personnel responsible for Clinical Data Systems implementation, operation and compliance. The course is of special value to personnel seeking experience with the quality issues associated with regulated computer systems.



Learning Objectives

The course will provide the tools needed to prepare for a Clinical Data System inspection and to assess risk areas that need prioritization. Attendees will learn how to review the system for regulatory vulnerabilities and to develop an action plan intended to close those gaps.




Course Description

This course focuses on preparation for FDA systems inspections whether establishing a new program or seeking improvements in an ongoing quality initiative. The course provides practical information for improving presentation and substance of Clinical Data Systems documentation in anticipation of a FDA Inspection. In addition, the course will address critical issues and potential observations resulting from a Clinical Data Systems audit.

The attendee will be able to develop action plans based on course material to improve the company's compliance position for an inspection. The executed plans will also strengthen evidence that the Clinical Data System performs to business and quality expectations.

Topics include the following: Inspection Fundamentals; Computer Validation and Part 11 Inspection Concerns; Assessing Standard Operating Procedures; Assessing System Documentation; Preparing for the Inspection and Maintaining Compliance.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers: info@cfpie.com
 
Deadline for Abstracts: n/a
 
Registration: http://www.cfpie.com/showitem.aspx?productid=034&source=hummolgen
E-mail: info@cfpie.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.