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Supplier Management for Medical Device Manufacturers 2017

Start Date:
Thursday, 23 March, 2017
End Date:
Friday, 24 March, 2017 6:00pm
Pain Management, Psychiatry, Internal Medicine, Emergency Medicine, Hematology, Pulmonary Medicine, Physical Medicine, Headache / Migraine

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: 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.Why should you attend?Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them.

But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supplier management program. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The C stands for current, meaning what the FDA considers the current state of the art in the areas they regulate.

Also European Notified Bodies also periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG). This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management.One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.

This seminar will review requirements and expectation of the FDA and European Notified Bodies for supplier management, and then how to incorporate these into your own supplier management process. Areas Covered in the Session:Understand FDA QSR and ISO 13485 requirements for supplier managementCreating a Risk-based Multi-tier supplier classification systemUnderstand when suppliers have to register and list with the FDADefining and using supplier MetricsExplain the link between design control and purchasing dataDevelop an risk-based supplier management process Incorporating supplier regulatory and safety riskIncorporating supplier business riskCreate supplier measurement and monitoring systemsUnderstand the how to develop and implement supplier controlsCreate a risk based Value-added system for supplier auditsHow to prepare yourself and your contract manufacturer for unannounced audits from your Notified bodyCreating acceptance criteria and understand how that fits into your supplier control process Who will benefit:Quality ManagersQuality EngineersAudit ManagersSupplier EngineersInternal quality auditorsSupplier auditorsQuality associatesQuality SpecialistsRegulatory Compliance Managers Agenda:Day 1 Schedule: Lecture 1:IntroductionsLecture 2:Fundamentals Regulatory RequirementsFDA RequirementsISO 13485 requirementsUnderstanding the role of the Global Harmonization Task Force GuidelineUnderstanding NBOC Guideline and why it should be usedLecture 3:Planning the Supplier Management ProgramSupplier ClassificationSupplier QA agreements what are they and why are thenDay 2 Schedule: Lecture 1:Planning Supplier SelectionLecture 2:Potential SuppliersLecture 3:Supplier SelectionLecture 4:Implementing Supplier ControlsLecture 5:Monitoring, Measuring, and EvaluationPeriodic MonitoringRe-evaluationsLecture 6:Supplier Audits - where do they add valuePlanning your supplier audit scheduleHow Notified Body unannounced audits affect your contract manufacturerWhat you should do to prepare yourself and your contract manufacturer for unannounced Notified body auditsLecture 7:Feedback and CommunicationSupplier meetings: Partnering with Key suppliersSupplier Corrective ActionsLecture 8:Evaluating your current program to see how it measures up to regulatory ExpectationsSpeaker: Betty LaneFounder and President, Be Quality Associates, LLC 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. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation.

Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.Betty's training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device - Quality Management Systems - System Requirements for regulatory purposes, and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (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 device and biotechnology 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 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 (RPI), and an MBA from Northeastern University.

Location: Washington, DC Date: March 23rd & 24th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Arlington Crystal City/Reagan National AirportAddress: 2899 Jefferson Davis Highway Arlington, VA 22202 USA Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until February 15, Early Bird Price: $1,295.00 from February 16 to March 21, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Quick Contact: NetZealous LLC DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email:


Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington,
22202 USA

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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