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ForwardSurviving an Inspection (On-demand)
Brought to you in partnership with the Alliance for Pharmacy Compounding
This is the on-demand version of the webinar. The live webinar was recorded on December 16th, 2021.
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 Type | Price (USD) |
| Pharmacist Member | $55.00 |
| Pharmacy Technician or Student Member | $35.00 |
| Non-member | $75.00 |
Intended audience
- Pharmacists, Pharmacy Technicians, & Pharmacy Owners
Learning Objectives
Pharmacists
- Review industry regulations for compounding pharmacies
- Investigate inspection techniques and appropriate responses during an inspection
- Recognize how to write effective responses to inspectional observations
Pharmacy Technicians
- Review how to respond appropriately while questioned during and inspection
- Investigate response methods ensuring correct and full answers
- 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) |
Software | No additional software needed |
Hardware | 2GB of RAM (minimum), 4GB or more of RAM (recommended) |
COPYRIGHT
This webinar is Copyright © Alliance for Pharmacy Compounding 2021.
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
| Type | Application-based |
| UAN | 0864-9999-21-071-H07-P/T |
| Credits | 1 CPE Hour = 0.1 CEUs |
| Release Date | December 16, 2021 |
| Expiration Date | December 16, 2024 |
COMPLETION REQUIREMENTS
- View the recorded webinar in full.
- Complete a learning assessment (minimum 80% passing grade, two attempts permitted) within 14 days.
- 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.
 | CPE 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.
| APC Members benefit from discounted pricing. Not a member? Click here to learn more! |
| Webinar Registration Fees | |
| APC Membership Type | Price (USD) |
| Pharmacist Member | $55.00 |
| Pharmacy Technician or Student Member | $35.00 |
| Non-member | $75.00 |
CANCELLATION AND REFUND POLICY
There are no refunds, returns or transfers upon purchase of the webinar.