Corrective Actions – Current expectation of ISO 13485 and FDA auditors - PowerPoint PPT Presentation

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Corrective Actions – Current expectation of ISO 13485 and FDA auditors

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Webinar will provide an understanding of current expectations of ISO 13485 notified body auditors regarding containment or correction of nonconformity. – PowerPoint PPT presentation

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Title: Corrective Actions – Current expectation of ISO 13485 and FDA auditors


1
  • Corrective Actions Current expectation of ISO
    13485 and FDA auditors

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
2
  • Instructor Profile
  • Betty Lane has over 30
    years experience in Medical Device quality
    assurance and regulatory affairs. She is the
    founder and President of Be Quality Associates,
    LLC, a consulting company helping small and
    medium sized medical device and diagnostic
    companies implement and improve their quality
    systems. Her work enables companies to manage
    their business in compliance with FDA and ISO
    13485 requirements, as well quality system
    requirements for other area such as Europe and
    Canada.
  • Her background in digital
    systems engineering enables her to facilitate
    design controls and software validation. Her
    areas of expertise include training, auditing,
    supplier management, document and records
    management, design controls, and software
    validation.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
3
  • Description
  • Earlier, ISO auditors have trained
    companies on the difference between Corrections
    (fixing the problem) and Corrective Actions,
    fixing the root cause of the problem. However,
    now, although corrections are usually being done,
    they are done under other portions of ISO 13485,
    such as control of nonconforming product and
    customer feedback/ complaints.
  • Even though ISO 13485
    requirements for Corrective Actions stress
    finding and correcting the root cause of a
    non-conformity, which is the essence of
    Corrective Action, that is not enough.
    Containment and Correction must now be an
    integral part of your system. With FDA's
    increasing emphasis on enforcement, doing robust
    corrections and corrective actions is a must.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4
  • Why Should you Attend
  • This presentation will benefit all
    those involved with internal or supplier
    corrective actions. If you issue corrective
    actions, you need to know what to expect of those
    assigned corrective actions, and often help the
    assignee understand the expectations. If you are
    assigned to complete a corrective action, you
    need to know what is to be expected of you in
    terms of investigation, analysis, and both
    correction and corrective actions.
  •   If you manage the corrective
    action system or those doing corrective actions,
    it is also important that you understand what you
    outside auditors expect of a strong CAPA system.
    So that means almost anyone working within a
    medical device quality system could benefit from
    understanding the CAPA system. 

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
5
  • Who can Benefit
  • This webinar will provide valuable
    assistance to all professionals in
  • Quality Management
  • CAPA coordinators
  • Quality Engineers
  • Engineers doing Corrective Actions
  • Operations managers
  • Manufacturing Engineers
  • Quality auditors
  • Medical device Consultants

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
6
  • Live Session - How it works
  • Username and Password will be sent to you 24
    hours prior to the webinar
  • Presentation handouts in pdf formate will be
    mailed to you
  • Login to the session using the username and
    password provided to you
  • Get answer to your queries through interactive
    QA sessions via chat
  • Please let us know your thoughts and views at the
    end of webinar, your valuable feedback will help
    us improve
  • Get certification of attendance.
  • Recorded Session - How it works
  • A link will be provided to you upon purchase of
    the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be
    mailed to you
  • Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
7
  • Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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