Excel Spreadsheets and FDA Device Regulations

Duration: 90 Minutes
This webinar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets are automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them.
Excel Spreadsheets
Instructor: Daniel O'Leary
Product ID: 500978

The webinar begins with Excel methods to help ensure the spreadsheet produces the results you want. It explains the built in Validation tools and how to use them to prevent the user from entering incorrect data. It also explains the use of Formula Auditing to help ensure the calculations are performed correctly. Lastly, the webinar explains the use of Protection to prevent inadvertent and unauthorized changes. To satisfy the broadest interest, the webinar uses Excel 2003 to illustrate the tools.

The webinar shifts to the regulations for automated processes, found in 21 CFR §820.70(i), and explains the requirements for a validation plan. The FDA Guidance document, General Principles of Software Validation, has a section devoted to this kind of software application. The webinar explains FDA’s thinking and shows how to follow the guidance document.

Why Should you Attend
FDA Inspections are based on ensuring compliance with the regulations. Failure to comply can result in the FDA citing the company for a violation, i.e., listing it on an FDA Form 483 Inspectional Observations. The FDA may even escalate these observations to a Warning Letter.

This webinar also looks into the electronic record aspects of the spreadsheet. 21 CFR §820.180 provides General Requirements for records. Part 11 has additional requirements when these are electronic records. The requirements for electronic records and some of the issues these requirements raise will be discussed.

Objectives of the Presentation
  • Overview of the regulations
  • Excel Validation
  • Using the Excel Convert Function
  • Excel Formula Auditing
  • Excel Protection
  • Track Changes
  • Understanding automated process in §820.70(i)
  • Electronic records and Part 11
Who can Benefit
This webinar is designed for people in medical device manufacturing who might use Excel spreadsheets. These are people involved in setting up any part of the production or quality system. Employees involved in selecting and evaluating contract manufacturers also need to understand these regulations. Attendees should have knowledge of manufacturing and quality system processes. This typically includes:
  • Quality Engineers
  • Production and Process Engineers
  • Manufacturing Engineers
  • Design Engineers
  • Purchasing Managers
  • Purchasing Agents
  • Supplier Quality Engineers
  • Quality Supervisors
  • Quality Inspectors
  • Quality Managers
  • Quality Audit Managers
  • Quality Auditors
Bonus Material
Participants will receive bonus material to help them implement the regulations:
  • A copy of the relevant section of the regulation annotated with information from the QSR preamble and QSIT
  • A copy of the Part 11 Guidance document
  • A copy of the software validation guidance document
$375
Recorded Session for one participant
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Instructor Profile:
Dan 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.
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