Not Specified. Denise Wrestler, ASQ CQE, CQA

account_circle
account_circle
account_circle

Profile

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
 

5 results Found
Live Webinar

NCMR Simplified - A One-Form, Easy-To-Complete, Method For Simplifying Your NCMR Process

This presentation will cover the FDA regulations (21 CFR Subpart I) regarding NCMR, how NCMR should be integrated into your CAPA system, how to best approach NCMR (including initiation, segregation, evaluation, investigation, notification, ...

  • Basic & Intermediate
  • 90 Mins
  • Jan 15, 2019
Live Webinar

Production And Process Controls - Ensuring Your Medical Device Conforms To Its Specifications

This presentation will cover the FDA regulations (21 CFR Subpart G Section 820.70) regarding production and process controls and how each requirement listed within the regulation can be addressed.  We’ll go over examples of documentation yo ...

  • Basic & Intermediate
  • 90 Mins
  • Feb 05, 2019
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, output ...

  • 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 ...

  • 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 ...

  • Basic & Advanced
  • 60 Mins