Excel Methods - FDA Device Regulations - 2017
- Start Date:
- Wednesday, 23 August, 2017
- End Date:
- Wednesday, 23 August, 2017 11:30am
- Health & Nutrition
Overview: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 planLearn methods to recognize the use of Excel workbooks in production or the quality systemUnderstand Excel workbook tools to help ensure spreadsheets are built correctlyUnderstand FDA's Part 11 and some of the implicationsLearn and apply Part 11 for electronic recordsWho Will Benefit:Quality EngineersProduction and Process EngineersManufacturing EngineersDesign EngineersPurchasing ManagersPurchasing AgentsSpeaker 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.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Netzealous LLC DBA - Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- Netzealous LLC DBA - Compliance4All