Production and QMS Software Validation - An Excel Example

Instructor: Daniel O Leary
Product ID: 702186
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This webinar covers production and QMS requirements for software (Excel spreadsheet) built into a medical device, as outlined in 21 CFR 820.70(i). Get practical advice on writing validation protocols and reports for Excel spreadsheets.

Course "Production and QMS Software Validation - An Excel Example" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

If you use software as part of your Production or Quality Management System (QMS) you must validate the software. This requirement is not the same as for software built into a medical device. Production and QMS software requirements are in 21 CFR 820.70(i). The most common occurrence of this kind of software involves an Excel spreadsheet. This webinar gives you practical advice on recognizing when this happens.

While the requirement applies to all production & QMS software, Excel spreadsheets are a good way to illustrate the methods. In addition, if you use Excel to create quality records, you may need to satisfy the Part 11 requirements.

The presentation explains the regulations in plain language and uses the FDA guidance documents to illustrate them. For validation, you will learn data checking methods in Excel and how to use them as part of a software validation approach. You will learn methods to document calculations in spreadsheets, prepare validation protocols, and produce validation reports.

For Part 11 compliance, you will learn about electronic records and when you create them. Using the regulation and FDA guidance document, you will learn what the FDA Inspector will check to determine if you use electronic records.

Areas Covered in the Seminar:

  • The QSR requirements for computers in production or the quality system.
  • The Part 11 requirements for electronic records.
  • Utilizing Excel's built in data validation methods.
  • FDA Guidance documents and their expectations.
  • Writing validation protocols and reports for Excel spreadsheet.

Who Will Benefit:

Moving a device from design to production often involves setting up production methods through design transfer. If this includes software for production, then the process needs to start in design. After design transfer, process effectiveness and efficiency improvements may introduce new or improved software.

People in the following roles can especially benefit from the knowledge in this webinar:
  • Design Engineers
  • Production and Process Engineers
  • Quality Engineers
  • Validation specialists
  • Quality Managers
  • Quality Auditors
  • Quality staff assigned to Customer Complaints or CAPA management

Instructor Profile:

Daniel 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.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
21 CFR Part 11 Compliance for SaaS/Cloud Applications - 80202SEM

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