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  6. Compounding Quality Center of Excellence | Instructor-Led Trainings
  1. Compounding Quality Center of Excellence

Compounding Quality Center of Excellence | Instructor-Led Trainings

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The FDA Compounding Quality Center of Excellence offers instructor-led training courses, in-person or virtually, to outsourcing facilities. Limited space also is available for pharmacy compounders and regulators. 

The in-person trainings offer practical activities for learning. These multi-day training courses provide continuing education (CE) credits for pharmacists, pharmacy technicians, physicians and nurses. Early registration is recommended.

The fee is $499 per person, per course.

These trainings are recommended for:

  • Operations, production and manufacturing personnel
  • Quality personnel, including quality control and quality assurance
  • Pharmacists
  • Facility and engineering personnel
  • Microbiologists
  • Laboratory personnel
  • Pharmacy technicians
  • Management
  • Senior leadership

Register for Courses

Request registration by clicking the registration link.

 
CourseDescriptionCE CreditsDatesLocationRegistration
Environmental MonitoringLearn how to develop an environmental monitoring program and various sample collection methods.15.25 hoursNovember 19-21, 2024Carlsbad, CARegister today
May 14-16, 2025Raleigh, NCRegistration opens January 2025
Visual Inspection – NEWLearn the basic principles, processes, and systems related to visual inspection of compounded drugs, including manual and automated visual inspection, defect classification strategies, training/qualification and inspection processes and challenges.12 hoursDecember 12-13, 2024Durham, NCRegister today
May 12-13, 2025Registration opens January 2025
CleanroomLearn to conduct cleanroom performance tests, such as airflow velocity and uniformity, high-efficiency particulate air (HEPA) filter leak testing and repairs and airflow visualization smoke studies.13.75 hoursJanuary 14-16, 2025Bethesda, MDRegister today
July 22-24, 2025Raleigh, NCRegistration opens March 2025
Investigations and Corrective and Preventive Action (CAPA)Learn science-based methodology, integrating problem-solving techniques from total quality management (TQM), Six Sigma, and Kaizen to identify the technical root causes, systemic root causes, corrective and/or preventive action and a control plan for preventing recurrence.16.50 hoursJanuary 27-30, 2025VirtualRegister today
August 11-14, 2025Registration opens April 2025
Sterile Drug CompoundingLearn the basic principles, processes, and systems related to sterile drug production through integrated principles of aseptic processing, sterile filtration, cleanroom operations, facility cleaning and disinfection, aseptic process simulation (media fills) and environmental monitoring.15.25 hoursFebruary 4-6, 2025Bethesda, MDRegister today
August 4-6, 2025Raleigh, NCRegistration opens April 2025
Data Integrity – NEWLearn key concepts to consider when designing processes that collect and utilize data and associated metadata to ensure data is complete, consistent, and accurate.12 hoursFebruary 25-26, 2025Durham, NCRegister today
June 12-13, 2025Registration opens February 2025
Quality Management Systems (QMS)Learn the fundamentals of establishing an effective quality management system and building a culture of quality within a facility, including information on the comprehensive QMS approach to quality and the critical role of senior leadership.15 hoursFebruary 27-28, 2025Durham, NCRegister today
June 10-11, 2025Registration opens February 2025
Process ValidationLearn general principles and approaches of process validation and the importance of ensuring control in the manufacturing process to produce consistent, quality drugs for patients. This course aligns process validation activities with a product lifecycle concept.15 hoursMarch 24-27, 2025VirtualRegister today

 

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