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Excel Spreadsheets and FDA Device Regulations  

Date & Time: Thursday, October 20, 2011

10:00 AM PDT | 01:00 PM EDT

Duration: 75 Minutes

Instructor: Dan OLeary

Location: Online

Price : $245.00

 

  

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(for one participant)

Instructor Profile:

Why you should attend: FDA Inspections are based on ensuring compliance with the regulations. Failure to comply can result in the FDA citing the company

Dan OLeary President, Ombu Enterprises

for a violation, i.e., listing it on an FDA Form 483 Inspectional Observations.

Areas Covered in the Session: l

Overview of the regulations ¡ ¡ ¡ ¡

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Automated processes Production and process changes General record keeping requirements Electronic records

Excel Validation ¡ Setting the validation criteria n Data types n Using lists to keep data consistent Developing an input message Developing an error warning message Using the Excel Convert Function ¡

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. ...more

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¡ Changing the unit of measure Excel Formula Auditing ¡ Tracing precedents and dependents ¡ Watching formulas

Error checking Circle Invalid Entries Excel Protection ¡ Locking and unlocking cells ¡ ¡

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Protecting a worksheet Protecting a workbook ¡ Selecting passwords Track Changes ¡ ¡

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How to turn it on The time limit for tracking changes Viewing history

Understanding automated process ¡ The regulation n The concept of validation n Establishing intended use ¡

n Establishing the validation protocol The guidance document n How much validation evidence is needed? n Defined user requirements

Validation of off-the-shelf software and automated equipment Electronic records ¡ General requirements for records n

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Definitions from Part 11 n Electronic records n Closed systems n Open systems Summary of requirements n Validation n System access

Audit trail Other requirements The guidance document n Enforcement discretion n n

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Electronic records . . . n in place of paper format n in addition to paper format

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records submitted to FDA in electronic format

Click here to register for this webinar Who Will Benefit: l l l l

Quality Engineers Production and Process Engineers Manufacturing Engineers Design Engineers

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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

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Excel Spreadsheets and FDA Device Regulations