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.

QSG’s Design Controls Concepts and Implementation course teaches participants what the FDA expects in terms of developing, implementing, and managing design control. Training also focuses on overcoming one of the biggest obstacles that routinely confounds device companies: accurately and consistently transferring product designs to actual manufacturing operations. In the end, participants will better understand what their companies need to include in a DHF and DMR, and, just as importantly, what FDA inspectors will be looking for when they review the records.

Upon completion of training participants will receive a Certificate of Completion to document training to senior management and FDA inspectors.

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
Through training, participants will:

  • 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
  • Learn to identify best practices for device design control and transfer
  • 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
  • Compare notes with other device manufacturers who face similar challenges

Course Outline

Why Does FDA Require Design Controls?

  • 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

FDA Guidance for Design Control

  • Defining a “substantially equivalent” production unit
  • Understanding difference between a deviation vs. nonconformance
  • Understanding difference between project design vs. product design
  • How international standards relate to FDA’s expectations low-up

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

Course Format
16 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
Course Instructor: Angelo Scangas – President and CEO

8:30am-4:30pm (EST) each day

Payment Type:
Date Attending
Name of Attendee(s)
Name of Company

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