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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
Product Marketing Departments
Every professional involved with selecting and qualifying suppliers for a new device design
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