Registration Design Control Requirements and Industry Practice
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.
Objective
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
The
course consists of 2½ days of intensive coverage and practical
application of the elements of design control.
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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.
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Faculty
Course faculty are drawn from an experienced group of quality system professionals. All course faculty have completed an instructor training program to ensure consistency and quality from session to session. The mix of industry leaders, consultants, and FDA personnel helps to ensure a balanced presentation of the design control requirements and paths to compliance.
Fees and Registration
Fees include the textbook, The Quality System Compendium; participant notebook of course materials and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
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