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The 6 Most Common Problems in FDA Software Validation and Verification

October 27, 10:00 AM PDT | 01:00 PM EDT| Duration: 120 Min

Sponsored by ComplianceOnline

Click Here to register $249.00

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

Why Should You Attend:

This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards.

Areas Covered in the Webinar:

  • Which data and systems are subject to 21 CFR Part 11 and Annex 11
  • Why compliance makes good business sense.
  • Details of FDA regulations/system features as applied to software: security, audit trails, electronic signatures.
  • Requirements for local, SaaS, and cloud hosting
  • The 6 Most Common Problems in FDA Software Validation & Verification.
  • Strategies on how to avoid the most common problems.
  • Advice on successful validation project staffing.
  • Avoid 483 and Warning Letters

Instructor Profile:

David Nettleton
FDA Compliance Specialist, ComputerSystemValidation

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. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 250 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.