Education Track Sessions

Cleanroom Design: Building for Quality and Compliance

This session is designed for pharmacy leaders and designated persons involved in home and alternative site infusion therapy cleanroom design projects. Attendees will learn how to apply Quality by Design (QbD) principles to optimize cleanroom design and layout planning, redundancy planning, HVAC design, space utilization, and future-proofing strategies. The session will focus on practical solutions that align with USP , USP , and regulatory best practices, helping teams make informed decisions when designing, renovating, or expanding their pharmacy cleanrooms.
This session is designed for pharmacy leaders and designated persons involved in home and alternative site infusion therapy cleanroom design projects. Attendees will learn how to apply Quality by Design (QbD) principles to optimize cleanroom design and layout planning, redundancy planning, HVAC design, space utilization, and future-proofing strategies. The session will focus on practical solutions that align with USP , USP , and regulatory best practices, helping teams make informed decisions when designing, renovating, or expanding their pharmacy cleanrooms.

Learning Objectives

  • Apply quality by design principles to optimize home infusion cleanroom design projects.
  • Develop HVAC and design redundancy strategies to minimize cleanroom downtime.
  • Evaluate cleanroom layouts to ensure alignment with regulatory standards and home infusion scalability needs.
  • Speaker(s)

    Elaine Strauss PharmD, MS, BCSCP Senior Managing Consultant
    WorkingBuildings - Trinity Consultants

    Kevin Hansen PharmD, MS, BCSCP Senior Director, Pharmacy Compounding Services
    Premier, Inc.

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