Compounding Quality Center of Excellence | Self-Guided Online Trainings
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The FDA Compounding Quality Center of Excellence provides training anytime, anywhere at no cost. Each course provides continuing education (CE) credits for pharmacists, pharmacy technicians, physicians and nurses.
Self Guided Online Trainings
| Training | Description | CE Credits |
|---|---|---|
| Aseptic Process Simulations (APS) (Media Fills) | Learn requirements and rationale for designing, performing and evaluating APS, including why integral media-filled units must be incubated and evaluated, and why failures must be thoroughly investigated by implementing appropriate corrective actions. Well-designed and executed APS help maintain control of the production process, ensuring drug quality and patient safety. | 2 hours |
| Cleanroom and Airflow Principles | Learn about proper cleanroom design, managing airflow and smoke studies. This course will help you prepare for the Cleanroom Design and Operation instructor-led training. | 4 hours |
| Insanitary Conditions and Sterility Assurance | Learn how to improve sterility assurance and prevent insanitary conditions to protect patients. Topics include commonly encountered insanitary conditions in non-sterile and sterile drug production and how to identify, mitigate and correct insanitary conditions. This course will help you prepare for the Sterile Drug Compounding instructor-led training. | 4 hours |
| Introduction to Visual Inspection | Learn the fundamentals of visual inspection, defect classification, acceptable quality limits (AQL), personnel training and qualification. This course will help you prepare for the Visual Inspection instructor-led training. | 1.25 hours |
| Investigations and Corrective and Preventive Actions (CAPA) | Learn how to conduct investigations and formulate CAPA. Discover elements that trigger investigations, investigative tools, developing and implementing CAPA, verifying effectiveness of CAPA and initiating and completing investigations and CAPA. | 5 hours |
| Outsourcing Facility Guide | Explore important regulatory information and statutory requirements for outsourcing facilities and compounders interested in becoming an outsourcing facility. Topics include adverse event reporting and other FDA guidance and requirements in section 503B of the Federal Food, Drug and Cosmetic Act. | 1.75 hours |
| Personnel Gowning in Sterile Drug Production | Learn the importance of maintaining sterile gowning components. Discover the proper steps to put on a sterile gown safely and minimize risk of contamination of your gown and the aseptic environment. | 0.5 hours |
| Regulatory Framework for Human Drug Compounding | Learn about human drug compounding, including the regulations, history and differences between sections 503A and 503B of the Federal Food, Drug and Cosmetic Act. Additional topics include FDA's inspection process and compounding oversight such as Form FDA 483s, warning letters and regulatory meetings. | 1.5 hours |
| Stability Program | Learn how to establish a stability program to support expiration dates or beyond use dates (BUDs). Topics include federal regulations, proposed enforcement discretion policies and fundamental technical aspects of stability studies, including expected specifications, methods and acceptance criteria, which are illustrated through case studies. | 4 hours |
| Sterility Testing: Common Misconceptions | Learn about sterility testing, including the impact of non-sterile drugs on patient safety and drug quality, common test method misconceptions, the critical elements of sterility testing and how to investigate sterility test failures. | 0.75 hours |
| Supplier/Contractor Qualification and Management | Learn how to select, qualify, manage and audit suppliers and contractors that provide supplies and services. Topics include federal regulations, FDA guidance documents and best practices for establishing quality agreements with a variety of suppliers and contractors. Discover the concept of supplier and contractor qualification and management lifecycles to avoid operational pitfalls and supply chain risks and ensure regulatory and quality compliance. | 4 hours |