FDAnews Announces — Medical Device Purchasing Controls: Building Compliant Systems Webinar, Oct. 20, 2016

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Manufacturers know their requirements for their supplier management program, but what does the FDA expect? Join industry expert Dan O’Leary on Oct. 20 for the Medical Device Purchasing Controls webinar when he’ll help attendees understand expectations using the regulations, their explanation in the QSR preamble, the GHTF guidance, and warning letters that illustrate the issues.

Medical Device Purchasing Controls:
Building Compliant Systems
**An FDAnews Webinar**
Oct. 20, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://info.fdanews.com/medical-device-purchasing-controls-pr

Manufacturers know their requirements for their supplier management program.

But, what does the FDA expect? Supplier selection… specification of purchased components or services… verification of items received?

How can manufacturers remain in compliance?

Join industry expert Dan O’Leary on Oct. 20 when he’ll help attendees understand expectations using the regulations, their explanation in the QSR preamble, the GHTF guidance, and warning letters that illustrate the issues.

After attending this 90-minute webinar attendees will be able to:

  •     Describe the elements of supplier evaluation and selection
  •     Develop “purchasing data” to define the component, service, and supplier requirements
  •     Maintain supplier records to demonstrate the systems effectiveness
  •     Establish procedures to accept or reject incoming product or services
  •     Explain the additional requirements in ISO 13485:2016

BONUS MATERIALS: Attendees will receive a QSR checklist for supplier selection and control and a comparative analysis in QSR, ISO 13485:2003 and ISO 13485:2016 requirements.
Register today and begin creating an integrated, efficient and compliant supplier management system.

Meet the Presenter:
Dan O’Leary is the President of Ombu Enterprises, LLC., a company offering training and execution in Operational Excellence, focused on analytic skills; and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including: aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Will Benefit:

  •     Purchasing managers
  •     Purchasing agents
  •     Quality managers
  •     Supplier quality engineers
  •     Inspection managers
  •     Manufacturing engineers
  •     Management Representatives

Webinar Details:
Medical Device Purchasing Controls:
Building Compliant Systems
Oct. 20, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://info.fdanews.com/medical-device-purchasing-controls-pr

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://info.fdanews.com/medical-device-purchasing-controls-pr                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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