Unit 3: Inspection Ready: Excelling in Sterile Compounding Compliance

Only available as part of a package

Participants will explore the roles of key regulatory agencies and healthcare accreditation organizations involved in pharmacy inspections and survey visits. The course will provide practical guidance on appointing a designated person, preparing staff for inspections, and responding effectively to deficiencies cited in inspection reports. By the end of the session, attendees will have a clear understanding of how to establish and manage competency processes that ensure compliance with USP <797> standards and support excellence in sterile compounding practice.

Learning Objectives:

  1. Describe the regulatory agencies and accreditation organizations that conduct inspections and surveys.
  2. Explain the role a designated person plays in preparing staff for inspection day.
  3. Identify who should draft and submit the official response to deficiencies cited in inspection reports.
  4. Develop a practical inspection-readiness plan to sustain continuous compliance. 

NHIA General CE Information

Zoe Glaras, PharmD, BCSCP

Pharmacy Manager, Sterile Compounding Quality & Compliance

Yale New Haven Health

Zoe Glaras attended the University of Connecticut School of Pharmacy where she graduated with her Doctor of Pharmacy. She spent her first decade of sterile compounding in the home infusion industry as an IV Pharmacist eventually advancing to Pharmacy Manager. Her passion for compliance led her to the CT Department of Consumer Protections Drug Control Division where she was a Drug Control Agent responsible for monitoring drugs, cosmetics, and device distribution systems for compliance with State and Federal laws and regulations. Zoe is currently the Pharmacy Manager of Quality and Compliance for the Yale New Haven Health Smilow Oncology Ambulatory sites where she manages the system's Sterile Compounding Quality and Compliance team and provides regulatory support on USP <797> and <800> to the the Smilow Oncology Ambulatory sites.

NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy. 

Zoe Glaras has no relevant financial relationships with ineligible companies to disclose.

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Unit 3: Inspection Ready: Excelling in Sterile Compounding Compliance
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Begin self-paced component package.
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8 Questions Sterile Compounding Designated Person Certificate Program Unit 3: Inspection Ready: Excelling in Sterile Compounding Compliance On Demand, 1.00 CE JA4008389-0000-25-236-H07-P&T & 203344936
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Up to 1.00 medical credits available  |  Certificate available
Up to 1.00 medical credits available  |  Certificate available **PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT** ________________________________________________________________________________________________________________________________________________________________________ NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity. Please note that the certificates printed from this platform are invalid as proof of continuing education (CE). For official documentation of CE credits, please print a paper statement of credit from your NABP e-profile.
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