Excel Methods – FDA Device Regulations – 2017

Excel Workbooks and FDA Device Regulations


FDA regulations cover both the use of workbooks and the creation of

electronic records device manufacturers must understand these regulations

and their application. The presentation begins with Excel methods to help

ensure the spreadsheet produces the results you want.

Why should you Attend:
Excel workbooks must produce correct results, so the first concept helps

ensure correctness. Excel workbooks may also cause regulatory problems,

because they are easy to implement and very common. Often people that

improve processes with these workbooks are not aware of the regulatory


Areas Covered in the Session:
Understand the pitfalls of using Excel workbooks without a good regulatory

Learn methods to recognize the use of Excel workbooks in production or the

quality system
Understand Excel workbook tools to help ensure spreadsheets are built

Understand FDA’s Part 11 and some of the implications
Learn and apply Part 11 for electronic records

Who Will Benefit:
Quality Engineers
Production and Process Engineers
Manufacturing Engineers
Design Engineers
Purchasing Managers
Purchasing Agents

Speaker 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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Ad Reference ID: 8265940d9295d0b3

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