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 In this section:

                Compounding Quality Center of Excellence

Compounding Quality Center of Excellence

                        Compounding Quality Center of Excellence | Instructor-Led Trainings
          Compounding Quality Center of Excellence | Self-Guided Online Trainings
          Compounding Quality Center of Excellence | Recorded Webinars
          Compounding Quality Center of Excellence | Annual Conference
          Outsourcing Facilities Annual Study
          Compounding Quality Center of Excellence | Cross-Sector Stakeholder Group Home
          Drugs
          Guidance, Compliance, & Regulatory Information
          Human Drug Compounding
          Compounding Quality Center of Excellence
          Compounding Quality Center of Excellence | Self-Guided Online TrainingsCompounding Quality Center of Excellence Compounding Quality Center of Excellence | Self-Guided Online Trainings
  
  	
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    PrintThe 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.

Training
			Description
			CE CreditsAirflow
			Learn about proper cleanroom design, managing airflow within the context of a cleanroom environment and conducting smoke studies that verify proper airflow management.
			4 hoursAseptic 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 hoursInsanitary 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 hoursInvestigations 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 hoursOutsourcing 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 hoursPersonnel 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 hoursRegulatory 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 hoursStability 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 hoursSterility 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 hoursSupplier/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

                                                                                  Content current as of:
      01/26/2024
              
              
Regulated Product(s)
		 DrugsCompounding Quality Center of Excellence

          
                        Instructor-Led Trainings
          Self-Guided Online Trainings
          Webinars
          Annual Conference
          Annual Study
          Cross-Sector Stakeholder Group
 
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