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 requirement.
Areas Covered in the Session:
Understand the pitfalls of using Excel workbooks without a good regulatory plan
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 correctly
Understand FDA's Part 11 and some of the implications
Learn and apply Part 11 for electronic records
Who Will Benefit:
Production and Process Engineers
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.
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