The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: June 21, 2016 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: compliancetrainings
Latest Activity: Jun 10, 2016
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
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