Speaker Profile

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.

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.



Speakers
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Avoiding an FDA Warning Letter with a Strong CAPA Program

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.

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