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Regulatory requirements for medical device companies seem to constantly undergo review and change, with increased emphasis on specific aspects based on recall, error and warning letter trends. Recent recalls of medical devices due to failures of critical components and services supplied to device manufacturers have resulted in increased scrutiny of Purchasing and Supplier Controls. The result is that manufacturers now bear the responsibility for every step in their supply chain to ensure they provide quality finished medical devices beyond what can be achieved through testing and inspection, meaning overall quality depends on quality of raw materials, components and services. In addition, manufacturers must make sure that all aspects of the supply chain are compliant with regulatory and quality system requirements.

Learning Objectives:
Upon completing this course, participants should be able to:

Understand the purchasing and supplier control requirements of the FDA QSR, EU MDR and ISO 13485: 2016
Evaluate effectiveness and applicability of these controls for their suppliers, raw materials, components and services using a risk based approach
Develop successful quality plans for incorporating requirements into the quality system

Who will Benefit:
This course is designed for people responsible for following purchasing procedures, those tasked with developing and improving purchasing and supplier controls including approval of suppliers, components, raw materials and services, and individuals responsible for quality management system improvements and compliance.

Following personnel will benefit from the course:

Quality professionals
Regulatory professionals
Compliance professionals
Purchasing supervisors
Manufacturing engineers
Design engineers

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

Contact the event managers listed below for more information about how you can participate at the FDA Scrutiny of Purchasing/Supplier Controls: 2-Day In-person Seminar.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Conference/Event Dates: 08/04/2016 - 08/05/2016
Conference/Event Hours: 8:30 AM to 4:30 PM
Classification: B2B
Primary Industry: Sciences
Other Industries: Business, Sciences
Estimated Attendance: 30
Cost to Attend: One Registration - $1699
Audience: Quality professionals
Regulatory professionals
Compliance professionals
Purchasing supervisors
Manufacturing engineers
Design engineers
Quality engineers
Venue: Venue TBD
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

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