Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11

Instructor: David Nettleton
Product ID: 701584
  • Duration: 60 Min
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Get a detailed understanding of how to perform risk assessment as part of the 10-step risk based approach to CSV.

Why Should You Attend:

In this webinar, participants will learn how to perform risk assessment as part of the 10-step risk-based approach to computer system validation. This distinct approach will help minimize project time by employing fill-in-the-blank templates. You can ensure compliance with QA, FDA, and clients. The instructor will use examples and real time scenarios to better illustrate the application of the techniques for any validation project.

Areas Covered in the Webinar:

  • How to use the risk-based approach to reduce validation time and lower costs
  • Step-by-step instructions for performing and documenting a risk assessment
  • How to use the results to reduce testing requirements
  • Avoid 483s and Warning Letters
  • How to identify risk in a process and establish mitigations to reduce liability

Who Will Benefit:

  • Computer system users
  • IT personnel
  • QA personnel
  • Managers
  • Executives

Instructor Profile:

Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. His wide knowledge on these subjects comes from his involvement in the development, purchase, installation, operation, and maintenance of computerized systems used in FDA compliant applications.

He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten Easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

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