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Overview

This presentation will cover the FDA regulations (21 CFR Part 820.198) regarding complaint handling, how to best approach complaints (including initiation, investigation, evaluation, and follow-up verification), examples of documentation you can use to successfully document complaints, as well as tips and tricks to what FDA auditors will look for when they come to visit your site.

 We will also go over some additional tips and tricks on how to ensure all negative feedback is correctly categorized within your organization and are processed correctly.

Why should you Attend

All medical device manufacturers are required to have a robust complaint handling system in place.  Does your company have one?  Is it easy to use?  Does it work?  Are you certain you know what constitutes a complaint?

At the end of the presentation, I will answer any questions or concerns you may have regarding the complaint handling process.

  • Get an in-depth understanding of what regulatory agencies such as the FDA are requiring for complaint files
  • Evaluate your already-existing complaint handling process to determine if it meets requirements
  • Determine if your system is robust enough to ensure all elements required for complaint files are incorporated within your operations
  • Overview of commonly-used systems and records
  • Understand some misconceptions with complaint file documentation
  • Tips and tricks for implementing a successful complaint handling system

Areas Covered in the Session

  • Regulatory requirements for complaints
  • Responsibilities of manufacturers
  • Best practices for complaint file records
  • FDA expectations
  • Documentation requirements

Who Will Benefit

  • Quality and Regulatory Professionals
  • Medical Device Companies

Speaker 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.