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INTERACTIVE
WEBINAR

 
Call-in teleconferencing 
 
Video demonstrations included in the presentation
 
 
 
610-399-4897
 

 

 

 
  


  
21 CFR Part 11 Compliance
 How to Save Money with Electronic Signatures and Records Compliance

 
June 3, 2010 WEBINAR
1 - 2:30 pm EDT
 
This webinar explains how to use electronic records and electronic signatures to significantly reduce costs. Learn exactly what is needed to be Part 11 compliant in all three compliance areas: IT infrastructure SOPs, software product features, and 10-step risk-based validation. You will be able to go paperless, immediately improve productivity, and reduce software implementation costs. 


Learning Objectives:

  • Understand which systems need and don’t need to be validated.
  • Learn compliance for electronic records: security, data transfer, and audit trails
  • Avoid 483 and Warning Letters.
  • SOPs required for the IT infrastructure.
  • Product features to look for when purchasing COTS software.
  • Electronic signatures, digital pens, and biometric signatures.
  • Save money and improve data integrity, security, and protect intellectual property.
  • Everything you need to know about Part 11 made understandable.


The Target Audience: 

  • Computer users
  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • GMP, GCP, GLP professionals

FEE: $365 for one person.
         $700 for 2-5 people
         $999 for 6-10 people
 

Instructor: David Nettleton 
Computer System Validation’s principal, 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. He has completed more than 192 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest 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. 
 
REGISTER NOW!  CLICK HERE!
610-399-4897
 
ECCWEB184