Title: Corrective Actions – Current expectation of ISO 13485 and FDA auditors
1- Corrective Actions Current expectation of ISO
13485 and FDA auditors
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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.
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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.
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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.
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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
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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
7www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com