NCMR Simplified - A one-form, easy-to-complete, method for simplifying your NCMR Process
Instructor:
Denise Wrestler
Product ID: 705876
Training Level: Basic
- Duration: 60 Min
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.
Areas Covered in the Webinar:
- Regulatory requirements for NCMR
- Responsibilities of manufacturers
- Best practices for NCMR implementation
- FDA expectations
- Documentation requirements
Who Will Benefit:
- Quality Assurance/Quality Control Directors, Managers, and Specialists
- Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
Denise Wrestler
QA and RA Consultant , CYA Medical Device Consulting LLC
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.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
