Live Webinar
on
Avoiding an FDA Warning Letter with a Strong CAPA Program
Date & Time: Thursday, March 29, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Mark Perkins
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview: The development and implementation of an effective CAPA system is not well understood by many device companies. This webinar is designed to clarify what the FDA is looking for in the CAPA system. Examples of warning letters will be reviewed to understand common themes found by FDA. Part of the problem is differences in terminology between the QSR and ISO 13485. This leads to confusion at times with the various team members involved in CAPA resolution. The differences in terminology will be clarified and an approach towards how to reconcile these within your system will be covered during this webinar.
Why should you attend: CAPA is a major subsystem of the FDA’s Quality System Regulation (QSR) and is always included in any QSIT inspection. Deficiencies in the CAPA system are consistently the top area of FDA 483 observations. A study of the FDA's EIR Turbo Database conducted for all 2010 data identified 1058 observations related to CAPA, making it number one
Mark Perkins RAC, ASQ Certified
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, prior to recruitment to AMS in San Jose, as the Director of Quality from 2010 through 2011, Mark has recently relocated to the San Diego area, and is currently consulting. ...more
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Areas Covered in the Session: l
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Understand FDA’s most common findings related to CAPA Review samples of warning letters published by FDA for deficiencies in the CAPA system Review and reconcile differences in FDA’s QSR and ISO 13485
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CAPA terminology Review examples of nonconformities and how they should be addressed in the CAPA system (Correction, Corrective Action,
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Preventive Action determination) Overview of how to define and document CAPA in the Quality System, including what needs to be included in the various
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stages of CAPA response, review and approval Address Ownership, Timelines and Escalation of CAPAs
Click here to register for this webinar Who Will Benefit: l
Regulatory Affairs professionals
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Quality Managers Quality Engineers Consultants
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R&D Management Quality System Auditors
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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