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