Virtual Professional Development Meeting – 2021 June


!!! Please make note – Virtual PD Meeting via WebEx !!!


Pandempact – an auditor’s perspective

Being an auditor of medical device companies provides unique insight into the effects of the COVID-19 pandemic.  For small and large companies alike, there has been a significant impact on all areas of the business – not just for medical device companies but for all industries around the globe.  This presentation will discuss the pandemic impact, or “pandempact” as certain circles have referred to it as, and as seen from an auditor’s perspective.


Denise Wrestler (ASQ CQE, CQA), has over 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals providing quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA’s “least burdensome approach” and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.    

Denise Wrestler holds a B.S. in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine. Additionally, Ms. Wrestler holds ASQ certifications as a Certified Quality Engineering (CQE) and Certified Quality Auditor (CQA), as well as BSI ISO 13485:2016 Lead Auditor certification. A contributing author to ASQ’s monthly publication Quality Progress magazine, Ms. Wrestler remains active within the quality and regulatory professional circles to ensure continuing education and awareness within the community. Ms. Wrestler has provided training, workshops, and presentations to small and large audiences alike on topics ranging from QSR, ISO 13485, auditing, and design control to risk management and regulatory readiness and preparation. 

!!! Please make note – Virtual PD Meeting via WebEx !!!

Meeting Information

Meeting Date: 24th June 2021
Meeting Time: 6:00 pm to 7:30 pm

Meeting Location:
Virtual Meeting

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