Wed September 16, 2015
Corrective Actions – Current expectation of ISO 13485 and FDA auditors | Webinar
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Topic ID: 000000252-web
Start Date: Sep 16, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: Corrective Actions – Current expectation of ISO 13485 and FDA auditors | Webinar
Details: This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered. Examples of each will be provided.
Areas Covered In The Session:
Overview of CAPA system for Current ISO 13485 compliance
Why Containment and Correction have been overlooked
Why this is a hot item with ISO auditors
What is really the difference between correction and corrective action
What kinds of containment can be done for Quality System nonconformities
Defining and documenting Containment actions - Quickly
Where does Preventive Action fit in
Examples of Containment actions
Speaker: 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 for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
Betty’s training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Devices and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.
For more details call Complystream at: (+1) 844 498 6361
show less
Start Date: Sep 16, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: Corrective Actions – Current expectation of ISO 13485 and FDA auditors | Webinar
Details: This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered. Examples of each will be provided.
Areas Covered In The Session:
Overview of CAPA system for Current ISO 13485 compliance
Why Containment and Correction have been overlooked
Why this is a hot item with ISO auditors
What is really the difference between correction and corrective action
What kinds of containment can be done for Quality System nonconformities
Defining and documenting Containment actions - Quickly
Where does Preventive Action fit in
Examples of Containment actions
Speaker: 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 for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
Betty’s training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Devices and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.
For more details call Complystream at: (+1) 844 498 6361
Topic ID: 000000252-web
Start Date: Sep 16, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: Corrective Actions – Current expectation of ISO 13485 and FDA auditors | Webinar
Details: This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered. Examples of each will be provided.
Areas Covered In The Session:
Overview of CAPA system for Current ISO 13485 compliance
Why Containment and Correction have been overlooked
Why this is a hot item with ISO auditors
What is really the difference between correction and corrective action
What kinds of containment can be done for Quality System nonconformities
Defining and documenting Containment actions - Quickly
Where does Preventive Action fit in
Examples of Containment actions
Speaker: 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 for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
Betty’s training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Devices and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.
For more details call Complystream at: (+1) 844 498 6361
read more
Start Date: Sep 16, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: Corrective Actions – Current expectation of ISO 13485 and FDA auditors | Webinar
Details: This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered. Examples of each will be provided.
Areas Covered In The Session:
Overview of CAPA system for Current ISO 13485 compliance
Why Containment and Correction have been overlooked
Why this is a hot item with ISO auditors
What is really the difference between correction and corrective action
What kinds of containment can be done for Quality System nonconformities
Defining and documenting Containment actions - Quickly
Where does Preventive Action fit in
Examples of Containment actions
Speaker: 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 for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
Betty’s training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Devices and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.
For more details call Complystream at: (+1) 844 498 6361
show less
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