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ForwardUSP <797> BEST PRACTICES – IT’S NOT JUST SOPs (PART 2): FROM CLEANING TO PACKAGING, HANDLING, STABILITY, DOCUMENTATION, & QUALITY ASSURANCE/CONTROL (ON-DEMAND)
AN APC WEBINAR POWERED BY LP3 NETWORK
This is the on-demand version of the webinar. The webinar was recorded on October 5th, 2023.
Overview
In a survey of best practices in over 600 compounders, only little more than half indicated to define and always follow standard operating procedures (SOPs) during sterile compounding processes (ISMP, 2020). While SOPs are crucial to ensuring best practices in sterile compounding, they are often times not regularly reviewed and updated to reflect areas experiencing significant change or new regulations to remain compliant with USP Chapter <797>.
This activity aims to highlight key areas of sterile compounding practices that are important to recognize as best practices to implement in your SOPs in order to remain compliant with USP <797>. In Part 2 of this 2-Part series, Amy Summers, PharmD, BCSCP, explores best practices in cleaning packaging, handling, stability characteristics, & quality assurance / control measures for sterile compounding.
To access Part 1 of this 2-Part series, click here.
Institute for Safe Medication Practices (ISMP). ISMP Survey Provides Insights into Pharmacy Sterile Compounding Systems and Practices. October 22, 2020. https://www.ismp.org/resources/ismp-survey-provides-insights-pharmacy-sterile-compounding-systems-and-practices
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 |
Please note: APC Members will be able to select their discounted pricing at checkout.
Intended audience
- Pharmacists & Pharmacy Technicians
Learning Objectives
Pharmacists
- Recall the importance of remaining compliant with the latest USP sterile compounding standards.
- Apply recent requirements/guidance for cleaning and disinfecting for sterile compounding.
- Identify revised USP <797> beyond-use date limits for compounded sterile preparations
- Review sterile drug packaging / labeling / handling procedures and quality assurance / control measures.
Pharmacy Technicians
- Recall the value of complying with the most up to date USP standards for sterile compounding.
- Apply recent requirements/guidance for sterile cleaning and disinfecting.
- Recognize USP <797> beyond-use date limits for compounded sterile preparations.
- Identify drug packaging procedures and quality assurance / control measures for sterile preparations.
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 2023.
| Amy Summers, PharmD, BCSCP |  |
Amy Summers, PharmD, BCSCP, is an independent consultant, specializing in business, operations, quality assurance, and regulatory compliance matters for the pharmaceutical compounding industry. Dr. Summers earned her PharmD degree from the University of California San Francisco and was among the first pharmacists in the nation to earn a Board Certified Sterile Compounding Pharmacist (BCSCP) credential.
Dr. Summers has spent her entire career as a pharmacist in various settings centered around non-sterile and sterile compounding. She has formerly served as Director of Operations and Pharmacist in Charge at organizations engaged in compounding and also as Managing Director of a FDA-registered 503B outsourcing facility. With extensive experience in USP standards, accreditation, cGMP, and regulatory compliance, Dr. Summers has also served as an expert witness for matters related to compounding.
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 | Knowledge-based |
| UAN | 0864-9999-23-063-H07-P/T |
| Credits | 1 CPE Hour = 0.1 CEUs |
| Release Date | October 5, 2023 |
| Expiration Date | October 5, 2026 |
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.
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 Type | Price (USD) |
| Pharmacist Member | $55.00 |
| Pharmacy Technician or Student Member | $35.00 |
| Non-member | $75.00 |
By registering for this Alliance for Pharmacy Compounding (APC) webinar, you confirm that your information, including contact information, will be shared with APC for direct marketing purposes.
CANCELLATION AND REFUND POLICY
There are no refunds, returns or transfers upon purchase of the webinar.