Non-conforming Product by Dan O Leary
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Website https://compliance2go.com/product/?pid=CP2014-414 |
Edit Freely
Category Medical Device
Deadline: February 15, 2015 | Date: February 16, 2015
Venue/Country: Online, U.S.A
Updated: 2015-01-26 16:05:59 (GMT+9)
Call For Papers - CFP
DESCRIPTIONNonconforming product, covered in 820.90, is one of the top ten most frequently cited sections in device Warning Letters. If you don’t have good procedures, and follow them, you may find yourself with a 483 or even a Warning Letter. Will your approach to control and disposition nonconforming product pass an FDA Inspection or a Notified Body audit?To develop good procedures, you must understand the regulations. This can be very confusing, because the dispositions are not well defined in either FDA QSR or ISO 13485:2003. In addition, the record keeping requirements are spread across QSR, making it difficult to identify them. There are also major connections to the Device History Record (DHR) and corrective action. This webinar can help you understand the requirements and implement them.Using clear language, the webinar explains the expectations for handling nonconforming product. The explanations are supported by the FDA’s inspection manual, QSIT. Examples from recent Warning Letters help you learn from mistakes and inform you of the issues Investigators identify.As a bonus, attendees will receive a checklist based on the regulations, Warning Letters, and QSIT to help ensure compliance.Areas Covered In the WebinarThe definition of nonconforming productThe standard dispositions and their definitionsThe difference between correction and corrective action as well as the types of correctionUncover the DHR requirements for nonconforming product rework ? they are not included in 820.184Learn how to document a decision to use nonconforming productUnderstand the need for retesting and reevaluation after rework and its relationship to acceptance activitiesLink the investigation of nonconforming product to corrective actionWho will benefit:People in the following roles can especially benefit from the knowledge in this webinar:Quality ManagersQuality EngineersQuality inspection and test managersProduction ManagersProduction SupervisorsManufacturing EngineersRegulatory affairs and compliance professionalsWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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