BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T115821Z UID:31161b07-8aa7-4fb0-8deb-287c593162e4 DTSTART:20210316T090000 DTEND:20210317T090000 CLASS:PRIVATE DESCRIPTION:
Supplier selection and management is one of the critical iss ues for medical device manufacturers. Suppliers provide materials and serv ices to the device manufacturer\, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notifie d body regulates your suppliers (with a few exceptions). They expect you t o have an effective process to ensure your suppliers perform in the regula tory environment.
\n\nHow well do you understand the requirements fo r supplier management?
\n\nCould you pass a regulatory audit or insp ection without any issues?
\n\nThis course delivers the tools\, temp lates\, and methods to help participants implement an effective and effici ent supplier management program.
\n\nThis two-day hands-on course pr ovides a clear understanding of the underlying principles of supplier mana gement. 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 i ncludes receiving acceptance activities\, outsourced processes\, process v alidation at the suppliers'\; location\, supplier auditing techniques\, and supplier issues in management review.
\n\nThe course uses the G lobal Harmonization Task Force (GHTF) framework\, but expands it to cover other issues and techniques important in effective implementation.
\n\nSince FDA regulations do not allow them to audit your suppliers unless they make finished medical devi ces\, they require that you have sufficient control over them. But from ti me to time the FDA makes a reinterpretation of what this means. This happe ned within the last f 5 years\, so if you supplier management program is o lder 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 F DA considers the current state of the art in the areas they regulate. Also European Notified Bodies also periodically update their expectations\, an d for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG).
\n\nThis seminar will go into the details of the NBOG supplier guidance document and a GHTF (Glo bal Harmonization Task Force) guidance that describes the current FDA expe ctation on supplier management.
\n\nOne of the major things introduc ed in these guidance document\, is the concept of Risk\, and the use of id entified risks as part of the evaluation and monitoring of suppliers.
\ n\nThis seminar will review requirements and expectation of the FDA and European Notified Bodies for supplier management\, and then how to incorp orate these into your own supplier management process.
\n\nIntroduc tions
\n\nFundamentals Regulatory Requirements
\n\nPlanning th e Supplier Management Program
\n\nPlann ing Supplier Selection
\n\nPotent ial Suppliers
\n\nSupplier Select ion
\n\nImplementing Supplier Con trols
\n\nMonitoring\, Measuring\ , and Evaluation
\n\nSupplier Audit s - where do they add value
\n\nFeedback and Communication
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Betty Lane \;has over 30 years'\; experience in Medica l Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates\, LLC\, a consulting company helping sm all 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 C anada. Her background in digital systems engineering enables her to facili tate 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 validat ion.
\n\nBetty'\;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 purpose
s\, and FDA Quality System Regulation - Medical Devices\; Good Manufacturi
ng Practice (cGMP)\, in companies where she worked as manager or director\
, and for AAMI\, ASQ biomedical division\, and ASQ sections. She has taugh
t courses in medical device and biotechnology quality and regulatory affai
rs 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 Instrument
ation (AAMI)\, The Society of Women Engineers and the IEEE. \;Bett
y has degrees in engineering from Rensselaer Polytechnic Institute (RPI)\,
and an MBA from Northeastern University.
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\nPlease contact Ma
rilyn Turner: Phone: +1 929 900 1853  \;Email: marilyn.turner [a] nyev
entslist.com for registrations