Risk Based Design Control by Edwin Waldbusser
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| Description: | DESCRIPTION This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. Such a program will also help to get projects completed on time and within budget. The important and confusing question of when, in a development process, Design Control begins will be answered. The difference between pre release and post release change control will be explained. The Design History File will be explained and a contents checklist discussed. The interrelationship between ongoing risk analysis and the design process will be explained. Why should you attend : Designing a medical device and testing it to prove it works is not sufficient in the eyes of the FDA to provide a safe product for users. The FDA has determined, through analysis of product recall data, that the majority of recalls were due to a faulty design process, not faulty manufacturing. These recalled products were tested before release and later failed in unanticipated ways that were not considered in the design and testing process. FDA also concluded that a well controlled design process with risk analysis, change control, design reviews, hardware/ software validation and feedback of the risk analysis results into the design process will greatly reduce chances of an unsafe product. Areas Covered in the Session: Reasons for design control When design control begins Elements of a design control program How risk managements fits into design control Change control Understanding validation consists of more than testing Design History File Who will benefit: (Titles) Development Engineers Production Management QA/ QC personnel Software developers Webinar includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 60 Minutes Live Presentation Certificate of attendance For Registration : http://c2gowebinars.com/product/?topic=design-control Note: Use coupon code < T9AIO8AY> and get 15% off on registration. |
| URL: | http://c2gowebinars.com/product/?topic=design-control |
| Date: | Thursday, April 7, 2016 |
| Time: | 5:00pm-6:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Created by: | Public Access |
| Updated: | Thursday, February 25, 2016 9:16am UTC |
| : | $179 |
| : | (877) 782-4696 |
| : | subscribe@compliance2go.com |
| : | David |
| : | 8777824696 |
| Comments: | None |