Why Should You Attend:
This presentation will provide an understanding of the two important guidelines now being use by FDA and ISO 13485 Notified Body auditors. This will allow you to make sure your supplier management and control system meets these guidelines, especially for outsourced processes including contract manufacturing, distribution, sterilization and testing. You depend on your suppliers, but can your system prove that you have sufficient control over especially your critical suppliers, to assure auditors and regulatory agencies that your product is safe and meets all your requirements?
In addition to defining the content of a supplier management program, the guidance documents require that you understand, define, document and control the risks related to all of your suppliers. This may include some of the suppliers of your suppliers. Supplier control has always been an FDA and ISO 13485 requirement, but the current expectation is that you actually document this control as part of your supplier management program, and most supplier control programs have not done this in the past.
As regulatory bodies are getting more pressure on them from governments and the general public, they have to use the tools of auditing quality management systems to make sure that manufacturers’ are producing safe and effective medical devices. Since particularly the FDA, cannot require your suppliers to meet the same quality system regulations that you do, they must do as much as they can to make sure you are exercising sufficient control over your suppliers. This presentation will help you prepare for the current expectations for evaluating and controlling your suppliers.
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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, 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.
As more virtual companies come into existence and most medical device companies are looking to increase their outsourcing, both ISO 13485 European Notified Bodies and the FDA are putting more pressure on companies to do an increasingly more rigorous job of controlling their suppliers. Following the GHTF supplier guidance document is now an expectation of both the FDA and most ISO 13485 auditors. In addition the operations group for European notified bodies (NBOG) released a guidance document outlining how your ISO 13485 auditors should be auditing you.
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