Webinar on Supply Chain Issues (21 CFR Part 820.50 and 820.80) and Warning Letters

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