Thursday April 5, 2018 6:00 p.m. - 8:00 p.m.
The Impact of Recent Regulatory Changes on Your Medical Device Quality System
There have been a number of changes in standards and regulations for medical devices in the last few years, including ISO 13485:2016 and new European Medical Device Regulations. In addition, Canada will require certification to the Medical Device Single Audit Program (MDSAP) starting in Jan. 2019. This presentation will give a brief overview of these new standards, regulations and requirements focusing primarily on their impact on medical device Quality Management Systems. The effect of these changes could mean that some companies not previously required to have a certified quality management system may now need to have one. We will also cover the participation in the MDSAP program by the US Food & Drug Administration, Japan, Brazil and Australia and what that means if you sell medical devices in these countries.
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 medical device companies implement and improve their quality systems for both business improvement and regulatory compliance. She has established or updated quality systems for numerous small and medium sized medical device and diagnostic companies enabling them to manage their business in compliance with FDA and ISO 13485 requirements. Her background in digital systems engineering, enables her to facilitate implementation of design controls and software validation. Other areas of expertise include training, auditing, quality management, document control, supplier management, and general safety compliance.
Betty is member of the American Society for Quality, Professional Society, Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the Institute of Electrical and Electronic Engineers. Betty has bachelors and masters degrees from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.
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Wednesday February 21, 2018
Managing the Complexity of Global Supply Chain Partnerships
Have you ever heard someone say that their company offshored to country X and the quality was terrible, or that when the product was moved to country Y and the costs went up, or that country Z rips off our IP. Is this done to us or do we allow it to be done unto us?
Supply Chain Management has become a global playing field in recent years. The common view point is that there has been a race to the lowest common denominator, offshoring technology and intellectual property to Asia and moving us the consumers farther and farther away from the centre of the supply chain. The concept of supply and demand are universal, the definition of quality and service are universal – providing the correct products at the correct price at the correct quality on time every time. Our local needs and expectations may change however and we need to be able to reflect this cultural shift in our supply chains. Add in to this ethical supply chains and our task of managing a complex supply chain becomes even more complex.
In this webinar we will address the central questions of (a) is globalisation a necessary constituent of modern supply chains and (b) what alternatives are necessary. We will look at the premise of ‘glocalisation’ in the supply chain environment – how can we apply the concepts of global supply chain management in a local environment. Finally we will review tools and techniques for building complex supply partnerships and why partnerships whereby all elements of the supply chain are working in unison for the customers customer and everyone is sharing the good fortune along the way
John is an ASQ Fellow and CQE, CQA, CMQ/OE, and CBA. His other certifications include: Massachusetts Quality Award Examiner, Lean Certificate Degree, and Certified Train-the-Trainer from Motorola University. He holds a BS in Industrial Engineering and an MBA in Finance. Currently, John is the QMS Manager at Philips Health Systems in Andover, MA. John is also an Adjunct Professor at Merrimack College.
In the course of his career, John has implemented ISO 9001 and Lean Manufacturing at various companies in various industries Worldwide. He speaks on Quality and Change Management at World and Local ASQ Conferences. John has also cerved as Chair for ASQMV.
Location (see map)
Holiday Inn Tewksbury –Andover
4 Highwood Dr
Tewksbury, MA 01876
5:30 - 6:00 Registration
6:00 - 7:00 Presentation
7:00 - 7:30 Dinner