Dates: FEB 23rd – 24th, 2015

Speaker: Betty Lane, Medical Device

Betty Lane, has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls including risk management, software validation and general safety.
Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the RAPS, Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.  

Course Description:

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

How well do you understand the requirements for supplier management?

Could you pass a regulatory audit or inspection without any issues?

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers’ location, supplier auditing techniques, and supplier issues in management review.

The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.

Reasons to attend:

Upon course completion, participants will:

• Understand FDA QSR and ISO 13485 requirements for supplier management
• Creating a Risk-based Multi-tier supplier classification system
• Understand when suppliers have to register and list with the FDA
• Defining and using supplier Metrics
• Explain the link between design control and purchasing data
• Develop an risk-based supplier management process
  • Incorporating supplier regulatory and safety risk
  • Incorporating supplier business risk
• Create supplier measurement and monitoring systems
• Understand the how to develop and implement supplier controls
• Create a risk based Value-added system for supplier audits
• How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body
• Creating acceptance criteria and understand how that fits into your supplier control process

Things you will receive as part of this seminar:

• Two guidance documents mentioned
• Example Approved Supplier list
• 2 examples or Supplier QA Agreements

Target Audience:

Anyone who need to expand their knowledge of supplier management requirements or best practices for supplier management:

• QA Specialists
• Internal auditors
• Consultants
• Quality engineers
• Quality Managers
• Supplier engineers
• Supplier auditors
• Product development personnel
• Production Managers
• Production Engineers
• Regulatory Affairs Managers
• Regulatory Affairs specialists
• Compliance Managers
• Human Resources Managers
• Executive Management

AGENDA:

Please Click  hear  for Agenda.

To Enroll for This Program today  please click hear

Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

http://www.complianzworld.com