Design Controls Concepts and Implementation

Course Summary

This course provides a practical understanding of the engineering value of design control throughout the product lifecycle as it pertains to product quality.

Event Details

8 hours

Instructor-led classroom training, in-person and in-groups, with opportunities to practice learned skills with data from trainees’ day-to-day jobs.

Available at QSG’s training facilities, on-site at your organization, and virtually


The successful development of medical devices requires that the design be controlled to ensure product safety and that the device can fulfill its intended use. This course provides a practical understanding of the engineering value of design control throughout the product lifecycle as it pertains to product quality. It includes the practical implementation of the design history file, reviews and records, transfer planning, engineering requirements and project planning. You will also learn topics related to design verification and validation testing, such as process validation and packaging validation. This highly interactive course engages the learner with an in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding of developing and applying design control requirements.

Who Should Attend

This course is designed 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 employees and companies that perform design activities.

Learning Objectives

Through training, participants will:

  • Learn to identify best practices for device design control and transfer
  • Learn to hurdle the biggest obstacle facing device companies: translating product design into real-world manufacturing conditions
  • Receive practical, actionable compliance advice straight from the source: former FDA inspectors, rule-makers, and trainers
  • Hear “lessons learned” by other device companies who have been cited by FDA for deficient or non-existent design controls
  • See how FDA rules relate to ISO, GHTF, and ICH standards – and save time and money with an integrated compliance blueprint
  • Learn to quickly capture feedback, both internal and external, to fine-tune a quality system and avoid product seizures and recalls

Course Outline

FDA Requirement

  • FDA’s major areas of concern
  • CDRH’s cradle-to-grave vision: The Total Product Life Cycle
  • Design control as part of the Quality System Regulation (QSR)
  • FDA’s definition of key design terminology

Design and Development Planning – 21 CFR 820.30

  • Implementing top-level design control procedures
  • Best practices in design planning
  • Design Review – 21 CFR 820.30 (e)
  • Types of review
  • Proven design review methods

Design Input – 21 CFR 820.30 (c)/ Design Output– 21 CFR 820.30 (d)

  • Understanding inputs vs. outputs
  • Typical input documents
  • Using FDA recognized standards and guidance
  • Important of Human Factor considerations
  • Other final output documents
  • Conducting design output review

Design Verification– 21 CFR 820.30 (f) / Design Validation– 21 CFR 820.30 (g)

  • Verification documents
  • Understanding difference between verification vs. validation
  • Elements of a test protocol
  • What FDA looks for in test reports
  • What if the design fails V&V?
  • How FDA defines validation
  • Key validation documents and methods
  • Conducting design validation review

Design Change – 21 CFR 820.30 (i) / Design Transfer to Manufacturing– 21 CFR 820.30 (h) / Design History File (DHFs) – 21 CFR 820.30 (j)

  • Developing a change control policy
  • Identifying all areas impacted by change
  • Conducting re-verification and re-validation
  • Integrating manufacturing considerations into design
  • Key design transfer documents
  • FDA requirements for design history
  • Relationship between the DHF and the Device Master Record (DMR)
  • Creating a traceable DHF index




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