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

2-day In-person Seminar: Computer System Validation - Reduce Costs and Avoid 483s

 
  May 08, 2012  
     
 
ComplianceOnline, Omni San Diego Hotel 675 L Street San Diego, CA
2012-06-21


Course Description :-

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential.

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Attendees learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

The instructor addresses the latest computer system industry standards for data security, data transfer,and audit trails. Students see how 21 CFR Part 11, the FDA regulation pertaining to use of electronic records and signatures, and the HIPAA electronic security regulations for patient medical records fit into the validation process. Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline SOP authoring, revision, review, and approval.

This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.

Course Objectives:-

  • Implement a computer system to gain maximum productivity and reduce cost by as much as two thirds.
  • Quickly cross train workers and see how to make use of temporary workers and outsourcing to promote growth and reduce costs.
  • "Right size" change control methods that allows quick and safe system evolution
  • Minimize the validation documentation to reduce costs without increasing regulatory or business risk.
  • Write test cases that trace to elements of risk management.

 

 
 
Organized by: ComplianceOnline
Invited Speakers:

Instructor :-

David Nettleton
FDA Compliance Specialist, Computer System Validation

David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. 

 
Deadline for Abstracts: 2012-06-22
 
Registration:
For Registration :-
 
E-mail: referral@complianceonline.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.