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 |
|---|---|---|
| Airflow | Learn about proper cleanroom design, managing airflow within the context of a cleanroom environment and conducting smoke studies that verify proper airflow management. | 4 hours |
| Aseptic Process Simulations (Media Fills) | Enhance your understanding of the statutory and regulatory requirements and rationale for the design, performance and evaluation of aseptic process simulations. Topics covered include why integral media-filled units must be incubated and evaluated, and the need to thoroughly investigate failures and implement corrective actions. | 2 hours |
| Insanitary Conditions and Sterility Assurance | Learn how to improve sterility assurance and prevent insanitary conditions to protect patient health. This course covers how insanitary conditions relate to sterility assurance, the most commonly encountered insanitary conditions in non-sterile and sterile drug production facilities and the consequences of each, the “systems approach” to sterility assurance and preventing insanitary conditions, as well as how to identify, mitigate and correct insanitary conditions. | 4 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 | Discover important regulatory information about the requirements specific to outsourcing facilities and practical information for areas such as registration for compounders that want to become outsourcing facilities and adverse event reporting. Other topics include the requirements in section 503B of the Federal Food, Drug, and Cosmetic Act and an overview of the major topics covered in key guidance documents. | 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 review the necessary techniques to minimize contaminating your gown or the aseptic environment. | 0.5 hours |
| Regulatory Framework for Human Drug Compounding | Enhance your understanding of federal law and policies applicable to human drug compounding, including an introduction to human compounding, a brief regulatory history and the differences between sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. The course also covers FDA inspection process and compounding oversight, such as Form FDA 483s, warning letters and regulatory meetings. | 1.5 hours |
| Stability and Beyond Use Dates | Learn policies, procedures and processes related to stability studies and beyond use dates (BUDs) as they relate to outsourcing facilities. Topics include regulatory requirements, technical aspects of establishing a stability program and BUDs, key concepts in designing a stability program, test requirements for stability testing methods and acceptance criteria, important aspects of testing compounded drug products, case studies and special situations. | 4 hours |
| Sterility Testing: Common Misconceptions | This course provides an overview of sterility testing, including the impact of loss of sterility on patient safety and product quality, common misconceptions, critical elements of sterility testing and investigating sterility test failures. | 0.75 hours |
| Supplier/Contractor Qualification and Management | Learn how to select, qualify, manage and audit suppliers and contractors. Topics covered by this course include regulations, guidance documents and best practices to improve the production of quality drug products. Participants will also learn about the concept of supplier/contractor qualification and management lifecycles. | 4 hours |