MEDTEC
 |
Advanced good manufacturing practices for medical devices will be the focus of a session scheduled for 9:00 to 16:00 on 20 September. Course instructors Christine Nelson and Annette Hillring will show participants how to integrate risk management into current quality systems and gauge the risk associated with medical devices. In addition, the session will detail the requirements of ISO 14971:2000, ISO 13485:2003, and US FDA’s quality system regulation. A retired US FDA employee, Christine Nelson has trained FDA field staff, as well as officials from the medical device industry and foreign governments. Annette Hillring has more than 23 years of experience in the field. She has been an independent regulatory affairs consultant since 1998, and, before that, was the director of regulatory affairs for Critikon (Tampa, FL, USA).
Two consecutive half-day presentations are also scheduled for 20 September. The morning session, which takes place from 9:00 to noon, will begin with a comprehensive overview of failure modes and effects analysis (FMEA), followed by a discussion of case studies and advanced applications of the process. The course will be led by Narenderpal Singh, a Dyadem International (Richmond Hill, ON, Canada) product manager. “What I hope to accomplish is to provide medical device manufacturers with the big picture of what goes into FMEA,” Singh explains. “Once medical device manufacturers understand how to maximize the effectiveness of other risk analysis and quality planning tools that are also available to them, they should find vast improvements in their product quality, process safety, and profitability,” he adds. At Dyadem, Singh manages the company’s FMEA software and is involved in the implementation of risk strategies in process plants, new product design and development, and reliability engineering consulting services. The afternoon workshop from 13:00 to 16:00 on 20 September will analyze the requirements of quality system software validation. Led by David A. Vogel from Intertech Engineering Associates (Norwood, MA, USA), the course will draw from Vogel’s experience in the medical device industry and as a member of an AAMI working group.
On 21 September, developing a quality management system that complies with ISO 13485:2003 and ISO 14969:2004 will be the focus of an all-day session. Course instructor Ed Kimmelman from Ed Kimmelman & Associates (Wilmington, DE, USA) has held engineering, product management, and senior management positions for DuPont and Roche Diagnostics during his 35-year career.
A daylong session on measurement error, also scheduled for 21 September, is described by course instructor Mark Crossley as a “very dynamic and hands-on tutorial.” The president of Quality Management Associates (Salisbury, NC, USA) and author of The Desk Reference of Statistical Quality Methods, Crossley describes measurement error as “a major problem” because it can adversely affect product acceptance decisions. During the morning portion of the session, Crossley will show how to use the central limit theorem to reduce equipment error. The afternoon portion of the session will cover Evolutionary-Simplex—a protocol for the evaluation of small, incremental changes to improve manufacturing processes. Workshop participants will perform a measurement error study and an Evolutionary-Simplex exercise. Tables and worksheets will be provided, but participants should bring a calculator.
For a complete MEDTEC Ireland conference programme, turn to page 42 or log on to www.medtecireland.com.
At the tabletop exposition adjacent to the conference, attendees will have the opportunity to source products ranging from packaging to electronics, from 10:00 to 16:30 daily. For a sample of what to expect, turn to page 43 for the MEDTEC Product Preview and page 48 for an exhibitors list.
MEDTEC Ireland is organized by Canon Communications llc, which publishes European Medical Device Manufacturer and Medical Device Technology. MEDTEC Ireland will be held at the Radisson SAS Hotel, Lough Atalia Rd., in Galway on 20 and 21 September.
For more information, contact the MEDTEC Ireland Help Desk, 36 Airways Ind. Est., Cloghran, Dublin 17, Ireland; phone: +353 1 8060557; fax: +353 1 8621482; e-mail: medtecireland@perform.ie, or visit www.medtecireland.com.
Copyright ©2006 European Medical Device Manufacture
