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. 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 and consultants helps to ensure a balanced presentation of the design control requirements and paths to compliance.
Fee and Registration
Fee includes PowerPoint presentations 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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