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  1. Human Drug Compounding

Compounding Quality Center of Excellence: Self-Guided Online Training Courses

The Compounding Quality Center of Excellence offers free, self-guided online training courses on quality manufacturing practice requirements and compounding policies pertaining to outsourcing facilities. These courses offer continuing education credits:

  • 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 FDA Form 483s, warning letters and regulatory meetings.
  • Airflow: Learn about proper cleanroom design, managing airflow within the context of a cleanroom environment and conducting smoke studies that verify proper airflow management. 
  • Insanitary Conditions and Sterility Assurance: Improve sterility assurance and prevent insanitary conditions to protect patient health. This course also 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 identifying, mitigating and correcting insanitary conditions.
  • Stability and Beyond Use Dates: Learn policies, procedures and processes related to stability studies and beyond use dating (BUD) as they relate to outsourcing facilities. Topics of this course include, regulatory requirements, the technical aspects of establishing a stability program and BUDs, key concepts in designing a stability program, the test requirements for stability testing methods and acceptance criteria, important aspects of testing compounded drug products, case studies and special situations. 
  • 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 FD&C Act and an overview of the major topics covered in key guidance documents.
  • Investigations and Corrective and Preventive Actions (CAPA): Learn how to conduct investigations and formulate corrective and preventive actions (CAPA). Discover elements that trigger investigations, investigative tools, developing and implementing CAPAs, verifying effectiveness of CAPAs and initiating and completing investigations and CAPAs.
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