Essentials of Dealing with Non-Conforming Material 2018

Topics

• Definitions and Expectations
• Overview of the Regulations
• Disposition of NC material
• Segregation and Control
• Acceptance Activities
• Concessions
• Correction and Corrective Action
• Failure Investigation
• Lessons Learned and Common Mistakes
• Documentation Requirements and Records
• Preparing for an FDA Inspection

Who should Attend

• Document Control Specialists
• Quality Systems Specialists
• Internal Auditors and Managers
• Quality and Compliance Specialists
• Manufacturing Managers
• Quality Engineers
• Supplier Quality Engineers and Auditors
• CAPA Specialists
• General Managers Wanting to Learn how to Understand Quality System Requirements
• Quality/Compliance Managers or Directors for Medical Device Companies