Boston Professional Events List


Live Webinar FDA Focus:Purchasing / Supplier Controls for Medical Devices


Date
Oct 18, 2017 - 01:00 PM
Organizer
conference Manager
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,
FLORIDA,
United States,
ZIP: 33021
Phone: 347 282-5400

Ticket Price: $17 One Dial-in One Attendee, $395 Group, $249 Recorded, $295 CD/DVD
Description

 

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control. You’ll learn about the essential elements of purchasing control and how you can translate them into your procedures. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.

Why Should You Attend

Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls.

Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations.   

 

Areas Covered

 

This 90-minute webinar will focus on establishing an effective and efficient system of purchasing controls. Topics to be covered include:

  • Understanding the regulations

  • Lessons Learned

  • FDA Expectations

  • Purchasing Controls Process

  • Planning

  • Evaluation of Suppliers

  • Purchasing Data

  • Performance Management

  • Feedback and Communication

  • Best Practices

  • Inspection Readiness

 

Who will Benefit

 

  • Supplier Engineers

  • Supplier Auditors

  • Supplier/Purchasing Managers

  • Quality Engineers

  • Supplier Quality Engineers

  • Compliance Personnel

  • Compliance Specialists

 

Industries who can attend

 

This 90-minute online course is intended for professionals in the in electronics, automotive, retail, and medical device Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel



Speaker Details


Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. 

Specialties: Quality, Compliance, Six Sigma, Lean Sigma, Quality Systems Development, ISO13485, ISO14971, GMP, QSR, CFR820, Quality Systems Auditing, Supplier Audits, Due Diligence, Predictive Compliance,Training and Education, FDA and Notified Body Inspection Readiness, Risk Management and Mitigation, Management Review, Quality Improvement, Supplier Management, Supplier Auditing, Process Validation, Problem Resolution, 483 / Warning Letter responses and mitigation.


Event Categories
Keywords: professional, Education




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