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, and disposition), examples of documentation you can use to fulfill the NCMR requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site.
The webinar will also go over some additional tips and tricks on how to convey the importance of NCMR within your organization and ensure resources are provided to meet process needs. At the end of the presentation, the speaker will answer any questions or concerns you may have regarding the NCMR process.
Learning Objectives:
- Regulatory requirements for NCMR
- Responsibilities of manufacturers
- Best practices for NCMR implementation
- FDA expectations
- Documentation requirements
Why Should You Attend:
All medical device manufacturers are required to have a robust system to control nonconforming materials and product. In the medical device industry, the system by which nonconforming material is controlled is known by many different acronyms (i.e. NCR, NCMR, NC, etc.). Does your company have one? Is it easy to use? Does it work? Are you certain you know what constitutes a nonconformance?
This presentation will help you get an in-depth understanding of what regulatory agencies such as the FDA are requiring for NCMR. The topics and pointers within the presentation will provide the tools necessary to evaluate your already-existing NCMR process to determine if it meets requirements and if the system is robust enough to ensure actions are effective or overly-complicated and preventing smooth operation.
We'll provide an overview of commonly-used NCMR tools, help understand some misconceptions with NCMR implementation, and provide tips and tricks for implementing a successful NCMR system.
Instructor 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.