Course opens: 

Surviving an Inspection (PFM On-demand)


In this activity, we will discuss how to prepare for and what to expect during an inspection. We will cover firm's rights during an inspection, common inspection techniques used by auditors and appropriate responses. Additionally we will go through common items investigated as well as common investigational findings in compounding pharmacies. Lastly, we will also cover how to write an effective response to the regulatory agency.

Intended audience

    • Pharmacists, Pharmacy Technicians, & Pharmacy Owners

    Learning Objectives


    1. Review industry regulations for compounding pharmacies
    2. Investigate inspection techniques and appropriate responses during an inspection
    3. Recognize how to write effective responses to inspectional observations


    Pharmacy Technicians

    1. Review how to respond appropriately while questioned during and inspection
    2. Investigate response methods ensuring correct and full answers
    3. Recognize common mistakes and techniques on how to avoid inspectional observations

    Hardware/software requirements

    Web browser

    Google Chrome (most recent 2 versions)

    Mozilla Firefox (most recent 2 versions)

    Internet Explorer v11

    Apple Safari (most recent 2 versions)

    Microsoft Edge (most recent 2 versions)

    Internet connection

    Computer: 1 Mbps or better (broadband recommended)

    Mobile device: 3G or better (WiFi recommended)


    No additional software needed


    2GB of RAM (minimum), 4GB or more of RAM (recommended)



    This webinar is Copyright © Alliance for Pharmacy Compounding 2021.

    Course summary
    Available credit: 
    • 0.10 CEU (ACPE)
    • 1.00 Contact Hours

    Melissa Stefko

    Melissa Stefko is an experienced Pharmaceutical and Biotechnology professional with a strong background in Quality Assurance and Quality Control in aseptic sterile processing. Prior to joining Wells Pharmacy Network, Ms. Stefko served as Head of Quality with a start-up 503B Outsourcing Pharmacy and gained a strong CGMP understanding throughout previous positions within compounding pharmacies and pharmaceutical manufacturers.

    Ms. Stefko is an active member of the American Society for Quality as a Certified Quality Auditor and Audit Chair for her local ASQ Chapter.  She is a member of Alliance for Pharmacy Compounding and serves on the Education Committee for APC. She is also a member of Institute of Environmental Sciences and Technology, American Society for Microbiology, Parenteral Drug Association, and APC.

    Ms. Stefko holds a Bachelors degree in Biology with a minor in Chemistry from Florida State University where she co-founded Pre-Pharmacy Informational Leadership and Learning Society (P.I.L.L.S.), a Masters in Business Administration, Masters of Science in Biotechnology, and Regulatory Affairs Certificate from University of Maryland Global Campus.

    Pharmacists & Pharmacy Technicians

    This CE Activity is accredited for Pharmacists and Pharmacy Technicians by the Accreditation Council for Pharmacy Education (ACPE) through CPE Consultants, LLC.

    Total CPE Credits: 1 CPE Hour = 0.1 CEUs

    Credits1 CPE Hour = 0.1 CEUs
    Release DateDecember 16, 2021
    Expiration DateDecember 16, 2024


    1. View the recorded webinar.
    2. Pay the credit reporting fee of $10.00 USD.
    3. Complete a learning assessment (minimum 80% passing grade, two attempts permitted) within  60 days of enrollment.
    4. Submit a completed live event evaluation form online within 60 days of enrollment.

    When the aforementioned steps have been completed and approved:

    • Pharmacists and Pharmacy Technicians registered in the United States will obtain a statement of completed credits on their NABP e-Profile within 60 days.
    • Pharmacists and Pharmacy Technicians registered elsewhere will receive an automated email from LP3 Network advising that they can download a statement of participation.
    • All participants will receive an automated email from LP3 Network advising that they can download the LP3 Network certificate of completion.
    accreditorCPE Consultants, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    International participants should verify with their respective governing board for accreditation equivalency.

    Please note: You can enroll in the course for free using the access code you were provided with, to get access to the slides and recording. The credit reporting fee of $10.00 USD only needs to be paid if you intend to claim credits. Upon payment, you will get access to the learning assessment and evaluation form, which must be completed to receive credits.


    There are no refunds, returns or transfers upon payment of the credit reporting fee.


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