Validating the Software That Powers Your Manufacturing Systems and Automated Processes - Webinar CD/Transcript

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Validating the Software That Powers Your Manufacturing Systems and Automated Processes

What does software validation require?

Clear thinking… good plans… solid execution… complete records.

All of these activities need support from QMS procedures that define responsibility, authority and methods.

Join industry expert, Dan O’Leary on Dec. 14 when he’ll discuss the FDA’s QSR requirements for validation of software used in both production and the quality management system.

After attending this 90-minute webinar you will:

  • Understand how and why the FDA is focused on this emerging threat area
  • Identify the systems that need validation and revalidation — many are systems you have likely taken for granted
  • Discuss the overlooked — practically ignored — standards and guidances that are the difference between a clean inspection and a warning letter
  • Be confident you have all the major elements necessary in an effective SOP for software validation
  • Understand why software validation and revalidation needs to be proportionate to the risk associated with the use of the software
  • Become an expert in writing validation planning docs and reports
  • Understand the application and benefits of black box and white box testing strategies
  • Explore the two new software validation areas in ISO 13485:2016 and their impact on your P&PC operations
  • Refresh yourself on the requirements in QSR, ISO 13485:2003 and ISO 13485:2016

BONUS MATERIALS: Participants receive a checklist for software validation and revalidation to help implement an effective program.

Order today for the solid framework you need for an effective implementation that helps assure correct results.

  • Production Managers
  • Production Supervisors
  • Manufacturing Engineering Managers
  • Manufacturing Engineers
  • Quality Managers
  • Quality Engineers
  • Reliability Engineers
  • Maintenance Managers
  • Maintenance Supervisors

Dan O’Leary is the President of Ombu Enterprises, LLC., a company offering training and execution in Operational Excellence, focused on analytic skills; and a systems approach to operations management. Dan has more than 30 years experience in quality, operations and program management in regulated industries including: aviation, defense, medical devices and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.