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    Live web seminar Non-conforming Product

    View: 221

    Website https://compliance2go.com/product/?pid=CP2014-414 | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: February 15, 2015 | Date: February 16, 2015

    Venue/Country: Online, U.S.A

    Updated: 2015-01-30 15:02:42 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    Nonconforming 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 Webinar

    The definition of nonconforming product

    The standard dispositions and their definitions

    The difference between correction and corrective action as well as the types of correction

    Uncover the DHR requirements for nonconforming product rework ? they are not included in 820.184

    Learn how to document a decision to use nonconforming product

    Understand the need for retesting and reevaluation after rework and its relationship to acceptance activities

    Link the investigation of nonconforming product to corrective action

    Who will benefit:

    People in the following roles can especially benefit from the knowledge in this webinar:

    Quality Managers

    Quality Engineers

    Quality inspection and test managers

    Production Managers

    Production Supervisors

    Manufacturing Engineers

    Regulatory affairs and compliance professionals

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.