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Overview

This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), examples of documentation you can use to fulfill the CAPA requirement, 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 convey the importance of CAPA within your organization and ensure resources are provided to meet CAPA process needs. At the end of the presentation, I will answer any questions or concerns you may have regarding the CAPA process.

Why should you Attend

  • Get an in-depth understanding of regulatory agencies such as the FDA requiring for CAPA
  • Evaluate your already-existing CAPA process to determine if it meets requirements
  • Determine if your CAPA system is robust enough to ensure actions are effective or overly-complicated and preventing smooth operation
  • Overview of commonly-used root cause analysis functions
  • Understand some misconceptions with CAPA implementation
  • Tips and tricks for implementing a successful CAPA system

Areas Covered in the Session

  • Regulatory requirements for CAPA
  • Responsibilities of manufacturers
  • Best practices for CAPA implementation
  • FDA expectations
  • Documentation requirements

Who Will Benefit

  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management
  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Software Developers
  • Usability engineers
  • Risk managers
  • Design Engineering Managers
  • Medical Device Engineering
  • Quality Assurance
  • Regulatory
  • Management

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.