Live Webinar
Excel Spreadsheets and FDA Device Regulations
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.
Unfortunately, many well meaning intentions may fail to satisfy the
regulations. For example, a manufacturing engineer may recognize
that an Excel spreadsheet could reduce the possibility of error in a
manual calculation. On its own, the spreadsheet would be a
valuable Preventive Action. However if the spreadsheet is not
validated, approved, and documented properly it may create a
problem during an FDA inspection. An unvalidated spreadsheet
violates the QSR requirements for automated processes.
Areas Covered in the Session:
l Overview of the regulations
l Excel Validation
l Using the Excel Convert Function
l Excel Formula Auditing
l Excel Protection
l Track Changes
l Understanding automated process
l Electronic records
Click here to register for this webinar
Who Will Benefit: Attendees should have knowledge of
manufacturing and quality system processes. This typically includes:
l Quality Engineers
l Production and Process Engineers
l Manufacturing Engineers
l Design Engineers
l Purchasing Managers
l Purchasing Agents
l Supplier Quality Engineers
Date:
Thursday, August 05, 2010
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
75 Minutes
Price:
$295.00
Register Now
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,
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