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Design Control Training for Drug-Device and Other Combination Products

Because of the additional complexity and risks associated with combination products, a design control plan should be put in place from product inception. Once established, the plan can be used to determine the adequacy of the design requirements and confirm that there are no negative interactions between its individual parts. The plan will also provide assurance that those parts, when combined, result in a combination product that performs as expected. In this class, you will learn how to apply control to the design process to ensure that your combination product meets user needs, intended uses, and specified requirements.

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Brief Overview of This Combination Products Design Control Class

SkillsLab Class ?

Class Content


Class Duration

5 Half-Days

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person

Certification of Completion


Continuing Education Units (CEUs)


* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days.

** Interested in private training for your team, virtually or in person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Design Control for Combination Devices Classes

SkillsLab $3295

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!


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Register 3 people, 4th attends free!


*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Class on Design Controls for Combination Drug-Device Biologic Products

Learn how to apply control to the design process to ensure that your organization's combination products meet user needs, intended uses, and specified requirements.

Course Overview
SkillsLab Class

Defining Combination Products

  • Combination product terminology, definitions, and examples
  • Primary mode of action (PMOA)
  • Manufacturing scenarios
  • Regulatory overview of combination products: US FDA and EU
Exercise! Identifying Combination Products

Introduction to Design Control

  • Reasons for design controls
  • Regulations and standards
  • Design controls and combination products
Exercise! Identify a Combination Product

Design Controls and Design Process

  • Elements of a process
  • Design control as a process
  • Process models for design and development
  • Design process efficiency
Exercise! Document a Process
Exercise! Define Your Process

Preparing for Design Control

  • Elements of project planning
  • Planning for design control
  • Product development life-cycle models
  • Design reviews
Exercise! Create a Development Plan

Human Factors, Usability, and Risk Management

  • Usability and human factors in the design control process
  • Risk analysis and management in the design control process
  • Linkages between design, usability, and risk management

Design Inputs, Outputs, and Reviews

  • Design inputs
  • Requirements
  • Design outputs
  • Traceability matrix
  • Design review execution
Exercise! Populate Fields In a Traceability Matrix

Design Verification

  • Design verification process
  • Risk-based sampling
  • Statistical justification
Exercise! Verification Methods

Design Validation

  • Design validation process
  • Layers of validation
Exercise! Validation Methods

Design Transfer and Design Files

  • Design transfer
  • Design history file (DHF), device master record (DMR), device history record (DHR), medical device file
  • Drug master file (DMF), master manufacturing record (MMR), batch production and control record (BPR)

Change Management

  • Design changes and control
  • Configuration management
  • Document control and change control; design change control
  • Postmarket sources of design changes, including new postmarket requirements under the EU MDR
  • Impact assessment

Auditing the Design and Development Process

  • FDA inspection techniques (QSIT) related to design controls
  • MDSAP outcomes and linkages related to the design and development process
  • Best practices in preparing for inspections and audits
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to

Identify design control regulatory requirements and standards applicable to combination products including ISO 13485:2016, US FDA, ICH, and the EU Medical Device Regulation.

Describe a process model for design and development.

Describe the role of usability and human factors in the design control process.

Evaluate the links between design, usability, and risk management.

Describe design review, design verification, and design validation processes.

Identify strategies for risk-based sampling and statistical justification.

Describe best practices for the design transfer process.

Practice design control process, building a design history file (DHF).

Describe postmarket surveillance and input to design changes.

Identify FDA inspection techniques (QSIT) related to design controls.

Identify Medical Device Single Audit Program (MDSAP) outcomes and linkages related to the design and development process.

Identify best practices in preparing for inspections and audits.

Who Should Attend

Who Should Attend

Recommended for anyone managing, developing, or engaging in the design of combination products or a constituent part of a combination product, including medical devices, drugs, or biologics. Recommended for those with direct engineering functions, QA/QC, production management, regulatory, and anyone else who has a role in building a robust regulatory-compliant environment. Experienced designers will also benefit from learning new trends associated with MDSAP, FDA Case for Quality, and changes in the EU regulations.

  • Engineers
  • Developers and Designers
  • QA/QA Personnel
  • Production Managers
  • Regulatory Personnel

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