Excel Workbooks and FDA Device Regulations - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)


The presentation helps participants understand the FDA's device regulations related to Excel workbooks. These workbooks could automate process, influence product decisions, support regulatory submissions, and create electronic records. 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. The methods include Data Validation (prevents the user from entering some incorrect data), Formula Auditing (helps ensure correct calculations), and Protection (prevents inadvertent and unauthorized changes).

The presentation explains the regulations for automated processes, 21 CFR §820.70(i) and the corresponding requirements from ISO 13485:2016. The FDA Guidance document, General Principles of Software Validation, has a section on production and quality system software. The presentation explains the guidance document's implementation. 21 CFR Part 11 includes requirements for electronic records. The presentation reviews the current guidance document, explains it application, and describes FDA's use of "regulatory discretion".

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. Notified Body audits or FDA Inspections uncover these applications and expect software validation, control of changes, etc. If your company uses Excel workbooks, you need to ensure control. This presentation provides the tools you need.

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
- Supplier Quality Engineers
- Quality Supervisors
- Quality Inspectors
- Quality Managers
- Quality Audit Managers
- Quality Auditors

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.
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