21 CFR 820 Design Controls

Design Control Concepts and Implementation

Course Description
To ensure that good quality assurance practices, consistent with quality system requirements worldwide, are used for the design of medical devices, the Food and Drug Administration has revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of this revision is the addition of design controls.

Because design controls must apply to a wide variety of devices, regulation does not prescribe practices that must be used. Instead, it establishes a framework that manufacturers must use when developing and implementing design controls. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes.

QSG’s Design Controls Concepts and Implementation course covers the basics of design controls for medical devices and provides participants recommendations for implementation of a design control system that meets all regulatory requirements without impeding timely market introduction. Design control requirements for devices already in distribution and documentation requirements for each design stage are included in instruction as well.

Who Should Attend
This course is appropriate for R&D personnel and management, Process and Quality Engineers, Quality Assurance management, Consultants, and Quality System Auditors. It will provide valuable assistance to any and all companies that perform design activities.

Learning Objectives
Upon successful completion of this course, participants will understand the basics of design controls and the process of implementing a compliant design control system.

Course Outline

  • Design Control History
  • Design planning
  • Design input/output
  • Design reviews
  • Design documentation
  • Design transfer
  • In-process design control

Course Format
16 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization

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