All, You are invited to the Northeast Product Safety Society’s 18th annual membership dinner featuring two keynote speakers from the Medical Device Consultants, Inc.. Our first speaker is Ms. Rosina Robinson, RN, Med, RAC, Principal Consultant of Regulatory Services and Dr. Judith Andrews, Ph.D., MDCI Director of Quality and Compliance Services. They will present details of the marketing authorization and maintenance of regulatory compliance for medical devices, with emphasis on the U.S. and the E.U. The dinner will be held on Wednesday, May 24th, at the Holiday Inn in Marlborough, MA.
If you will be in the area on May 24th, please consider joining us for dinner and the opportunity to mingle with interesting people involved with product safety. If you are not yet an NPSS member, this is a great opportunity for you to become a member. IEEE PSES members can join NPSS at no additional charge by submitting an NPSS application. Further information about the NPSS 18th annual membership dinner will soon be available at http://www.nepss.org. The Buffet Dinner will include: Virginia Ham, Teriyaki Sirloin Tips, Mixed Vegetable, Red Potatoes, Melon, Green Salad, Coffee, Tea and Desserts. Please RSVP by May 22nd as reservations are required If you are planning to attend please make your reservations today or as soon as possible so NPSS may make proper accommodations with the hotel for the number of people attending. If you are planning to attend, please make your reservations with Donna Kearney at 978-486-8880 X272 or e-mail at [email protected]. There is no charge to NPSS members whose dues are paid before the dinner on May 24th. There is a $35 nominal fee to non-NPSS members. Please provide any special dietary requirements information with your reservation confirmation and every attempt will be made to provide for your needs. You can verify your membership status at the NPSS web site which will soon be updated. A membership application form is available at http://www.nepss.org/membership/npssbroc.txt. Whether you are a paid NPSS member or not, please update your contact profile at http://www.nepss.org/membership/profileupdate.html. Ms. Rosina Robinson will discuss the commonalities and differences of the EU/FDA marketing authorization process as well as touch on harmonization efforts in the regulatory area. Dr. Judith Andrews will discuss compliance with design controls, managing post market risks and how companies have run afoul of the Agency (warning letters, etc.), key compliance issues for inspections and audits, and finally, verification, validation, and risk. There will be handouts of the information presented by our speakers. Rosina Robinson has over thirty years of experience in regulatory affairs and healthcare delivery. Prior to joining MDCI in 1992, she was Manager of Clinical Research and Regulatory Approvals at Haemonetics Corporation where her responsibilities included management of clinical trials and preparation of FDA submissions. Her experience includes development of regulatory strategy for a wide variety of medical devices, clinical trial design, and the entire spectrum of U.S. pre market applications, as well as Canadian License Applications. Ms. Robinson is a member of the Regulatory Affairs Professional Society (RAPS), the Association of Operating Room Nurses, and the American Association of Blood Banks. She is a registered nurse, holds a M.Ed. degree from Bridgewater State College, and is Regulatory Affairs Certified (RAC). Dr. Judith Andrews has over fifteen years of experience in the area of FDA regulated medical devices. Prior to joining MDCI, she was responsible for quality control and quality assurance at Cytologix, Inc., a start-up in vitro diagnostic company. She has experience with pathology, immunology, and neuroreactive reagents and systems, as well as consumer products. She holds an M.B.A. degree from Simmons Graduate School of Management, a Ph.D. degree in Chemistry from Case Western Reserve University, and a B.A. degree in Chemistry from Hanover College. She is a member of the Regulatory Affairs Professionals Society (RAPS) and a member of the American Society for Quality (ASQ). Additional information about the keynote speakers and their presentation will soon be available at http://www.nepss.org. The Dinner agenda is 6:00 – 6:50 – Registration & Social (Cash bar) 6:50 – 7:00 – Opening remarks and Welcome message from Steve Brody, NPSS President 7:00 – 8:00 – Dinner 8:00 – 8:10 – Introductions by Steve Brody, NPSS President, Paul Smith, Assistant VP of Meetings, will introduce our keynote speakers. 8:20 – Keynote speakers Further information about the Northeast Product Safety Society and how to become a member is available at http://www.nepss.org. Directions to the Holiday Inn: The Holiday Inn is located on 265 Lakeview Drive (Rt. 20), Marlborough, MA (508-481-3000). From I-495 North or South, take exit 24A (Rte. 20 East / Marlborough) and take your first left into the Holiday Inn Drive. The hotel will be on the hill. We are looking for a few volunteers to help on the registration table on the 24th. If you would like to be one of these volunteers, please contact David Wheeler, Dinner Chairman, at [email protected] or myself at [email protected]. Matt Campanella NPSS Secretary Compliance Engineer Motorola, Inc. Broadband Communications Sector 111 Locke Drive Marlborough, MA 01752 (508) 786-7629 Direct (508) 786-7500 Main (508) 480-6332 Fax [email protected] email - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
