RAPS Pre-Approved Webinar on “Avoiding an FDA Warning Letter With a Strong CAPA Program†From Gl
Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, €Avoiding an FDA Warning Letter with a Strong CAPA Program€ on November 8. This 90-minute webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion. Mark Perkins, a registered Professional Engineer, will be the speaker at this webinar.
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Description:
This webinar gives an idea of how to put a strong CAPA program that passes an FDA check during a visit.
A strong CAPA is a critical requirement as a subsystem of the FDA's QSR. Shortfalls in the CAPA system are the biggest reason for issuance of observations and 483's from the FDA. It could also lead to FDA oversight and making violations known publicly.
The development and implementation of a sound CAPA system is a must, but most medical devices companies don't seem to realize what goes into it. It is noticed that one of the reasons medical device companies have a problem in putting a strong CAPA in place is that they usually don't differentiate between the terminologies of the QSR and ISO 13485. This is often a source of confusion, to the extent that there are overlaps between the two.
This webinar session will sort this confusion out. It will offer ways by which the two can be integrated into the CAPA system. It will explain what needs to go into the CAPA system to make it robust; how to appropriately document responses, reviews and approvals, and what to keep in mind regarding timelines and escalation.
It will also offer examples of warning letters, and what need to be done to avoid them. It will also offer an understanding of how to deal with ISO 13485 surveillance audits, which too look for good CAPA systems.
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When:November 8, 10:00 AM PDT | 01:00 PM EDT
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By whom:Mark Perkins began his career in Aerospace in 1983 and transitioned into Medical Device QA/RA in 1998. He held management positions in QA/RA in Class I, II and III device companies from 1998 to 2008. He established a consulting practice, working with various medical device companies between 2008 and 2010. Mark has recently relocated to the San Diego area, and is currently consulting.
Mark is a registered Professional Engineer in the state of California, is RAC (US) certified through RAPS, and is ASQ Certified (CQE, CQM, CQA). Mark received his BS in Industrial Engineering from Texas A&M in 1983, and his Advanced Certificate in Regulatory Affairs from San Diego State University in 2006.
Mark has been active with RAPS, serving as the Registration Manager and then Device Programs Manager with the SF chapter from 2009 to 2011. He also has been active with Silicon Valley ASQ (RAPS Liaison) and the ASQ Biomedical Division Northern California Discussion Group.
Mark has presented on CAPA, Complaints, Corrections and Removals at both RAPS and ASQ sponsored events and other venues.
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For whom:
The webinar will benefit
o Regulatory Affairs professionals
o Quality Managers
o Quality Engineers
o Consultants
o R&D Management
o Quality System Auditors
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Duration: 90 minutes
-----------------------------------------------------------------------------------------------------------------
To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407
ARTICLE LINK
-----------------------------------------------------------------------------------------------------------------
Description:
This webinar gives an idea of how to put a strong CAPA program that passes an FDA check during a visit.
A strong CAPA is a critical requirement as a subsystem of the FDA's QSR. Shortfalls in the CAPA system are the biggest reason for issuance of observations and 483's from the FDA. It could also lead to FDA oversight and making violations known publicly.
The development and implementation of a sound CAPA system is a must, but most medical devices companies don't seem to realize what goes into it. It is noticed that one of the reasons medical device companies have a problem in putting a strong CAPA in place is that they usually don't differentiate between the terminologies of the QSR and ISO 13485. This is often a source of confusion, to the extent that there are overlaps between the two.
This webinar session will sort this confusion out. It will offer ways by which the two can be integrated into the CAPA system. It will explain what needs to go into the CAPA system to make it robust; how to appropriately document responses, reviews and approvals, and what to keep in mind regarding timelines and escalation.
It will also offer examples of warning letters, and what need to be done to avoid them. It will also offer an understanding of how to deal with ISO 13485 surveillance audits, which too look for good CAPA systems.
-----------------------------------------------------------------------------------------------------------------
When:November 8, 10:00 AM PDT | 01:00 PM EDT
-----------------------------------------------------------------------------------------------------------------
By whom:Mark Perkins began his career in Aerospace in 1983 and transitioned into Medical Device QA/RA in 1998. He held management positions in QA/RA in Class I, II and III device companies from 1998 to 2008. He established a consulting practice, working with various medical device companies between 2008 and 2010. Mark has recently relocated to the San Diego area, and is currently consulting.
Mark is a registered Professional Engineer in the state of California, is RAC (US) certified through RAPS, and is ASQ Certified (CQE, CQM, CQA). Mark received his BS in Industrial Engineering from Texas A&M in 1983, and his Advanced Certificate in Regulatory Affairs from San Diego State University in 2006.
Mark has been active with RAPS, serving as the Registration Manager and then Device Programs Manager with the SF chapter from 2009 to 2011. He also has been active with Silicon Valley ASQ (RAPS Liaison) and the ASQ Biomedical Division Northern California Discussion Group.
Mark has presented on CAPA, Complaints, Corrections and Removals at both RAPS and ASQ sponsored events and other venues.
-----------------------------------------------------------------------------------------------------------------
For whom:
The webinar will benefit
o Regulatory Affairs professionals
o Quality Managers
o Quality Engineers
o Consultants
o R&D Management
o Quality System Auditors
----------------------------------------------------------------------------------------------------------------
Duration: 90 minutes
-----------------------------------------------------------------------------------------------------------------
To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407
ARTICLE LINK
