The FDA Investigators are increasingly looking at the processes used by firms to qualify their suppliers, auditing levels applied to suppliers and service providers, the incoming inspection of the components, and the level of scrutiny of these controls, based on the risk assessment of these.
This presentation will review the regulatory requirements for the Medical Device Quality System Regulations, guidance documents and a review of the citations, which the Agency has written to firms in their Warning Letters. This presentation will provide a better understanding of what the FDA expectations are for Purchasing Controls, how to better document your firm’s activities and control components and services at the earliest points vs. when it fails on the line or in distribution.
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