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. We 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, Speaker will answer any questions or concerns you may have regarding the NCMR process.
Why You Should 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 Session :
Regulatory requirements for NCMR
Responsibilities of manufacturers
Best practices for NCMR implementation
FDA expectations
Documentation requirements
Who Should Attend:
Quality Assurance Departments
Regulatory Affairs Departments
Engineering Departments
Production Departments
Documentation Departments