Sterile Compounding Preconference

The CAPA Games: May the Root Cause Be Ever in Your Favor

Even in the most controlled environments, cleanroom excursions happen. This session will take a real-world approach to root cause analysis (RCA) and corrective and preventative action (CAPA) planning following a cleanroom incident in a home infusion setting. We will explore the difference between surface level fixes and meaningful, sustainable improvements that meet accreditation and regulatory expectations. Attendees will work through case scenarios and common pitfalls, helping leaders and clinicians feel confident navigating investigations, documenting outcomes, and implementing effective change.
Even in the most controlled environments, cleanroom excursions happen. This session will take a real-world approach to root cause analysis (RCA) and corrective and preventative action (CAPA) planning following a cleanroom incident in a home infusion setting. We will explore the difference between surface level fixes and meaningful, sustainable improvements that meet accreditation and regulatory expectations. Attendees will work through case scenarios and common pitfalls, helping leaders and clinicians feel confident navigating investigations, documenting outcomes, and implementing effective change.

Learning Objectives

  • Identify common types of cleanroom incidents and classify them based on risk level and required response.
  • Develop clear, compliant CAPA plans that include accountable parties, timelines, and auditing.
  • Differentiate between corrective and preventive action plans with examples of weak and strong CAPA documentation.
  • Speaker(s)

    Aubrey Hersch PharmD Director of Clinical Services, Pharmacy
    Soleo Health

                array(6) {
      [0]=>
      string(17) "Session Organizer"
      [1]=>
      string(19) "Symposium Organizer"
      [2]=>
      string(22) "Learning Lab Organizer"
      [3]=>
      string(13) "ISC Organizer"
      [4]=>
      string(16) "Industry Contact"
      [5]=>
      string(17) "Theater Organizer"
    }
                
    Speaker

    Share:

    Registration for the Sterile Compounding Preconference Required