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This presentation is primarily directed to medical device quality personnel and other staff who are selecting, auditing and receiving purchased components and services (design control, quality, purchasing, and internal auditors). Also, those who receive customer owned products for servicing. Areas Covered in the Session : FDA Quality System requirements Guidance document review, if any Review of Warning Letter citations What to do: Auditing activities (visits vs. surveys) Sampling plans/ship to stock/etc. Documentation of procedural controls/activities to demonstrate compliance Interactive Q&A Session Who Will Benefit: Quality Control Departments Regulatory Affairs Departments Research & Development Departments Production Departments Quality Engineers Product Marketing Departments Every professional involved with selecting and qualifying suppliers for a new device design
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