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» Annette Hillring and Tammy M. Pelnik
Next course:
October 21-23 2009, Copenhagen, Denmark
Course Venue:
» IDA Mødecenter, Copenhagen
Agenda:
Day 1: 8.00-17.00 Registration 07.30-08.00
Day 2: 8.00-17.00
Day 3: 8.00-12.00 + Lunch
Price:
€ 2.295 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
www.aami.org(The Association for the Advancement of Medical Instrumentation)
Industry field:
Medical Device industry
Course description:
This intensive 2½-day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. The program has been revised to include more hands-on exercises, more "how-to" information on implementation of design control requirements, increased focus on life cycle aspects of risk management and human factors, and more up-to-date industry examples.
Learning objectives:
Upon completing this course, participants will be able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet both regulatory and business requirements.
Format:
This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Participants have cited FDA participation and the opportunity to hear FDA expectations and perspectives, firsthand, as one of the most valuable aspects of the learning experience.
Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. During this highly interactive learning experience, participants are given ample opportunity to discuss the different approaches that can be taken depending on company size or device classification.
Program At-A-Glance
| Day 1 08.00-17.00 |
Intro. to Design Control |
Design Input |
| Day 2 08.00-17.00 |
Design Review (cont.) |
Risk Management |
| Day 3 8.00-12.00 |
Design Changes |
12.00 Lunch (optionally) |
Who should attend:
Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams. In 2006, FDA brought the course in-house to train Office of Compliance employees.
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com