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Ms.Denise Wrestler, ASQ CQE, CQA
Area Of Expertise : Medical Devices
20 Years Of Experience
Training Industry : Life Sciences
Denise Wrestler, ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides 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). 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
3 results Found
Recorded Webinar
The DIOM – A straightforward method for meeting FDA requirements for Design Inputs and Outputs
A DIOM, or Design Input Output Matrix, is a very common tool used by medical device companies to show compliance to FDA 21 CFR Part 820.30, Design Controls, as well as ISO 13485:2016, Section 7.3, Design and Development. Design inputs, outputs, verification and ...
- Intermediate
- 60 Mins
Recorded Webinar
FDA Part 820 Basics – Everything you need to know to get your start-up company compliant
This presentation will cover the basics of 21 CFR Part 820, including “human translations” to these often hard-to-read regulations. We will cover the basic systems that are required to be established and maintained for your medical device company and a basic plan of ...
- Basic
- 90 Mins
Recorded Webinar
CAPA Simplified - A one-form, easy-to-complete, method for simplifying your CAPA Process
This CAPA evaluation, implementation and integration webinar will discuss FDA regulatory requirements, how to evaluate your CAPA system, how to integrate with QMS and the best practices approach to initiation, evaluation and implementation of CAPA system along with d ...
- Basic & Advanced
- 60 Mins