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Elevating Sterile Compounding Practices: Quality Control and Assurance Essentials Webinar

Target Audience: Pharmacist

star star star star star_outline 3.9/5 based on 37 ratings
schedule 1.00 Contact Hours (0.10 CEUs)
category Compounding
local_activity Knowledge

Course Overview

Quality control and quality assurance are integral to ensuring the safety, efficacy, and compliance of compounded sterile preparations (CSPs). United States Pharmacopeia (USP) Chapter <797> defines quality control and assurance. This continuing education activity focuses on the essential principles, processes, and regulatory requirements of quality control and assurance in sterile compounding.

Learning Objectives

Upon completion of this educational activity, participants should be able to:

  • Compare and Contrast quality control and quality assurance
  • Describe the essential components of quality systems in sterile compounding
  • Describe adverse event reporting

Faculty

Authors & Activity Planners
Liz Fredrickson, PharmD, BCPS
View Bio +
Liz Fredrickson is an Associate Professor of Pharmacy Practice and Pharmaceutical Sciences at the Northeast Ohio Medical University College of Pharmacy. She serves as the Director of Instructional Labs and is course director for the Basic Pharmaceutics Lab and Parenteral Products and Parenteral Products Lab courses.
Pamela Sardo, Pharm.D., B.S.
View Bio +
Pamela Sardo, Pharm.D., B.S. is a licensed pharmacist and Freelance Medical Writer at Sardo Solutions in Texas.

I. Introduction

II. Definitions

III. Essential Components of Quality Systems in Sterile Compounding

A. Facility Design and Environmental Controls
B. Personnel Training and Competency
C. Competency Testing in Aseptic Manipulation
D. Documentation
E. Standard Operating Procedures
F. Master Formulation Records
G. Compounding Records

IV. Risk Assessment and Mitigation

V. Quality Control Measures

A. Verification
B. Sterility and Endotoxin Testing

VI. Notifications, Inspections, Recalls, Complaint Handling, and Adverse Event Reporting for CSPs

A. Inspections
B. Reporting
C. Key Components of Reporting
D. Encouraging a Culture of Reporting

VII. Summary

From April 28, 2025 through April 28, 2028, participants must:

  1. Read the "learning objectives" and "author and planning team disclosures"
  2. Study the section entitled "educational activity"
  3. Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

Credit for this course will be automatically uploaded to CPE Monitor®.

Faculty Planner Disclosure

The following individuals were involved in developing this activity: Liz Fredrickson, PharmD, BCPS, and Pamela Sardo, PharmD, BS. Pamela Sardo and Liz Fredrickson have no conflicts of interest or financial relationships regarding the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.

Unlabeled Use Disclosure

The information provided in this course is general in nature and it is solely designed to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice. Healthcare professionals, including pharmacists and pharmacy technicians, must consult with their employer, healthcare facility, hospital, or other organization, for guidelines, protocols, and procedures they are to follow. The information provided in this course does not replace those guidelines, protocols, and procedures but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits. Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses are constantly changing, and any person taking this course understands that such person must make an independent review of medication information prior to any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only and such uses are not endorsed hereby. Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course, or course material.

Please ensure the device you plan to use meets these requirements:

  • Operating System: Windows 7, 8, 10, or 11 / Mac OS X 10.9 or later / iOS / Android
  • Supported Browsers: Microsoft Edge, Firefox, Google Chrome, Safari, Opera
  • A connection to the internet

Accreditation

In support of improving patient care, RxCE.com is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.