Excel Methods - FDA Device Regulations - 2017

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:

• Quality Engineers
• Production and Process Engineers
• Manufacturing Engineers
• Design Engineers
• Purchasing Managers
• Purchasing Agents