Management Responsibility by Dan O Leary
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| Description: | DESCRIPTION The FDA’s Quality System Regulation (QSR) prescribes a medical device manufacturer’s Quality Management System (QMS). The webinar describes the five components of Management Responsibility by reviewing the regulations, inspection methods, and Warning Letters. The webinar examines the requirements for management responsibility using FDA based information. We examine the regulation in 21 CFR §820.20, discuss its constituent parts, and explain the many defined terms. The webinar draws on many sources to provide the understanding you need for an effective implementation. One rich source is the preamble in which FDA-CDRH responded to suggestions and comments about the draft regulation. The Quality System Inspection Technique (QSIT) guides Investigators during an inspection. QSIT includes flow charts and narrative that the webinar incorporates. Warning Letters represent problems that FDA Investigators uncovered during inspections and provide an opportunity for you to avoid them. Areas covered in the webinar: The five components of Management Responsibility The special terms that FDA uses The approach an FDA Investigator takes using QSIT Warning Letters to illustrate some of the issues encountered Tips for successful implementation Who will benefit: Device company executives Device company managers Management Representatives Quality Assurance Managers Regulatory Affairs Managers Why you should attend: This is a key area in an effective management system for quality. In this webinar you will learn the requirements, understand how to implement them, and learn what FDA Investigators expect when they check your compliance. Webinar includes : A bonus checklist to help guide effective implementation Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 90 Minutes Live Presentation Certificate of Attendance For Registration :http://c2gowebinars.com/product/?topic=management-responsibility-dan-o-leary Note: Use coupon code <T9AIO8AY > and get 15% off on registration. |
| URL: | http://c2gowebinars.com/product/?topic=management-responsibility-dan-o-leary |
| Date: | Monday, April 18, 2016 |
| Time: | 5:00pm-6:30pm UTC |
| Duration: | 1 hour 30 minutes |
| Access: | Public |
| Created by: | Public Access |
| Updated: | Tuesday, April 12, 2016 4:23am UTC |
| : | $179 |
| : | (877) 782-4696 |
| : | subscribe@compliance2go.com |
| : | David |
| : | 8777824696 |
| Comments: | None |