FDAnews Announces: Medical Device Supplier Quality Management: Are You and Your Suppliers Compliant? Workshop, Nov. 30 – Dec. 1, 2016, Arlington, VA

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In order to avoid citations manufacturers need to make sure their supplier quality related procedures are compliant. James Shore and John Freije, Co-Authors of “Proactive Supplier Management in the Medical Device Industry” will provide the tools, templates and methods to help you implement an effective and efficient supplier management program at the Medical Device Supplier Quality Management: Are You and Your Suppliers Compliant? workshop.

Medical Device Supplier Quality Management:
Are You and Your Suppliers Compliant?
Nov. 30 – Dec. 1, 2016 – Arlington,VA
http://www.fdanews.com/mdsupplierqualitymanagement

Purchasing controls and supplier management continue to be target-rich environments for FDA investigators issuing Form 483s.

Manufacturers continue to struggle with the implementation of both adequate procedures and effective tools needed to manage suppliers.

The requirements of Part 820.50 are fairly interpretive, giving you some wiggle room to achieve compliance.

But the bottom line is in order to avoid citations; manufacturers need to make sure their supplier quality related procedures are compliant.

There are two experts with deep knowledge who can provide an overview and up-to-date knowledge of purchasing controls for quality assurance and control of purchased components, services or finished medical devices.

James Shore and John Freije, Co-Authors of “Proactive Supplier Management in the Medical Device Industry” will provide the tools, templates and methods to help you implement an effective and efficient supplier management program at the Medical Device Supplier Quality Management: Are You and Your Suppliers Compliant? workshop.

After two days of 'total immersion' study, attendees will return to the office with increased understanding based on team exercises and case studies … informative, detailed explanations … and honest no-holds-barred discussions with James and John as well as your fellow attendees.

After this workshop attendees will be able to:

  •     Understand the changes to ISO 13485:2016 specific to supplier controls
  •     Identify the potential changes to your quality systems that you should put in place
  •     Use the Total Risk Factor and Total Cost of Ownership tools to identify and mitigate risk
  •     Explain the regulatory agency current expectations regarding the necessary controls on purchased or otherwise received product and services
  •     Describe the requirements needed to effectively select and manage suppliers in a state of compliance
  •     Identify tools necessary to properly monitor suppliers and evaluate ongoing quality based on risk

Who Will Benefit:

  •     Quality assurance/quality control
  •     Operations
  •     Manufacturing
  •     Materials management
  •     Purchasing
  •     Packaging and labeling
  •     Plant engineering
  •     Laboratory quality control
  •     Regulatory affairs
  •     Legal counsel
  •     Engineering Managers
  •     Quality Engineers
  •     Production Engineers
  •     Purchasing Managers
  •     Purchasing Agents involved in outsourcing production or processes
  •     Design Engineers
  •     Project Managers involved in design and development

Conference Details
Medical Device Supplier Quality Management:
Are You and Your Suppliers Compliant?
Nov. 30 – Dec. 1, 2016 – Arlington,VA
http://www.fdanews.com/mdsupplierqualitymanagement
Tuition: $1,797
Significant team discounts are available.

Easy Ways to Register
Online: http://www.fdanews.com/mdsupplierqualitymanagement
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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