Chapter 29: Importance of Design Control and Risk Management Processes in Combination Product Development

  • Harold K. YeagerEmail author
  • Mary Roesner Brokovich
  • Beat U. Steffen
  • Michael J. Roe
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)


Core to managing a combination product’s life cycle is a quality system outlining robust design controls and risk management processes. Competent monitoring processes and a multidisciplinary governance structure providing oversight empower efficient and patient-centric product development while facilitating accountability and management awareness throughout.


Design controls Risk management Governance Quality systems Product lifecycle 

Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  • Harold K. Yeager
    • 1
    Email author
  • Mary Roesner Brokovich
    • 2
  • Beat U. Steffen
    • 3
  • Michael J. Roe
    • 4
  1. 1.Yeager Device Solutions, LLCIndianapolisUSA
  2. 2.FishersUSA
  3. 3.confinis agSurseeSwitzerland
  4. 4.Kaléo, Inc.RichmondUSA

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