Course opens: 
12/16/2021

Surviving an Inspection

Overview

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.


Pricing

 

APC Members benefit from discounted pricing.
Not a member? Click here to learn more!
Webinar Registration Fees
APC Membership TypePrice (USD)
Pharmacist Member$55.00
Pharmacy Technician or Student Member$35.00
Non-member$75.00

Please note: APC Members will be able to select their discounted pricing at checkout.

 


Intended audience

    • Pharmacists, Pharmacy Technicians, & Pharmacy Owners

    Learning Objectives

    Pharmacists

    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

    We will be using Zoom for this webinar - full system requirements can be found here. You can download the Zoom client here.

    Web browser
    • Windows: Internet Explorer 11+, Edge 12+, Firefox 27+, Chrome 30+
    • macOS: Safari 7+, Firefox 27+, Chrome 30+
    • Linux: Firefox 27+, Chrome 30+

    Internet connection

    • ~600kbps (down) for high-quality video
    • ~1.2-1.8Mbps (down) for 720p HD video 
    • ~2-3Mbps (down) for 1080p HD video

    Misc

    • Speakers – built-in, USB plug-in, or wireless Bluetooth

    Hardware

     MinimumRecommended
    ProcessorSingle-core 1Ghz or higherDual-core 2Ghz or higher (Intel i3/i5/i7 or AMD equivalent)
    RAMN/A4 GB

     


    COPYRIGHT

    This webinar is Copyright © Alliance for Pharmacy Compounding 2021.

    Course summary
    Available credit: 
    • 0.10 CEU (ACPE)
    • 1.00 Contact Hours
    Price:
    $75.00

    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 activity is eligible for ACPE credit; see final CPE activity announcement for specific details.


    COMPLETION REQUIREMENTS

    1. Attend the live webinar in full (login and logout times will be recorded).
    2. Complete a learning assessment (minimum 80% passing grade, two attempts permitted) within 14 days.
    3. Submit a completed live event evaluation form online within 14 days.

    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: APC Members will be able to select their discounted pricing at checkout.

    APC Members benefit from discounted pricing.
    Not a member? Click here to learn more!
    Webinar Registration Fees
    APC Membership TypePrice (USD)
    Pharmacist Member$55.00
    Pharmacy Technician or Student Member$35.00
    Non-member$75.00

    The webinar will be live on Thursday, December 16th at 2:00pm Eastern Standard Time (EST).

    Not able to attend live? Register for the on-demand version instead - the recording will be posted within a week following the live webinar.


    CANCELLATION AND REFUND POLICY

    There are no refunds, returns or transfers upon purchase of the webinar.

    Price

    Price:
    $75.00
     
    Status
    Price
    Title
    $75.00Included
    Please login to Enroll or Add to Waitlist
    $75.00Included
    Please login to Enroll or Add to Waitlist
    $75.00Included
    Please login to Enroll or Add to Waitlist
    Please login to Enroll or Add to Waitlist
    Course expires: 
    12/16/2021