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

 
  November 19, 2012  
     
 
ComplianceOnline, Scottsdale, AZ
2013-02-07


Course Objective:

The seminar is designed to provide a detailed overview on implementing a computer system validation to gain maximum productivity and reduce costs by as much as two thirds. Following are the main objectives of the two day interactive seminar:

· How to make use of temporary workers and outsourcing to promote growth and reduce costs.

· Implement control methods that allow quick and safe system evolution.

· Minimize the validation documentation to reduce costs without increasing regulatory or business risk.

· Protect intellectual property and keep electronic records safe.

· Write efficient test cases that trace to elements of risk management.

Important contents covered in the seminar are:

· 21 CFR Part 11 - Compliance for Electronic Records and Signatures

o Avoid 483 and Warning Letters

o Three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.

o Ensure data integrity, security, and protect intellectual property.

o SOPs required for the IT infrastructure.

· HIPAA Compliance for Electronic Records

o How part 11 and HIPAA interrelated

· The Five Keys to COTS Computer System Validation

· Ten-Step Process for COTS Computer System Validation

· How to Conduct a Hazard Analysis/Risk Assessment-Exercise

· How to write efficient test cases to reduce software testing

· How to manage a validated system with minimal documentation

· Cost Reduction Without Increasing Regulatory or Business Risk

Who will benefit

This course will be beneficial for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. This can be valuable to the following personnel who use computer system to do their job functions.

  • Regulatory Affairs
  • QA/ QC
  • IT/IS
  • Software Managers
  • Project Managers
  • Software vendors and suppliers
 
 
Organized by: ComplianceOnline
Invited Speakers:

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. His most popular book is Risk Based Software Validation - Ten easy Steps (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project

 
Deadline for Abstracts: 2013-02-06
 
Registration:

 
http://www.complianceonline.com/ecommerce/control/seminar?product_id=80005SEM 
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.