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 $249 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
- Regulatory affairs
Register for Courses
Request registration by clicking the registration link.
| Course | Description | CE Credits | Dates | Location | Registration |
|---|---|---|---|---|---|
| Quality Management Systems (QMS) | Learn the importance of establishing an effective QMS and building a quality culture in your organization. Gain an understanding of a comprehensive QMS approach to quality and the critical role of staff and senior leadership. Learn to apply concepts by responding to real inspectional observations, reinforcing your ability to identify and correct QMS deficiencies. | 15 hours | September 28-29, 2026 | Seattle, WA | Register today |
| Data Integrity | Learn how to establish robust data integrity practices that ensure regulatory compliance and protect patient safety. In this comprehensive training, pharmacists and other compounding personnel will discover how to design, implement and maintain processes that collect and use data and associated metadata while ensuring accuracy, consistency and completeness throughout the data lifecycle. | 12 hours | September 30 – October 1, 2026 | Seattle, WA | Register today |
| Visual Inspection | Learn the fundamentals of visual inspection, including manual and automated visual inspection, defect classification, acceptable quality limits (AQL) and training / qualification. Practice applying a risk-based approach to assess and detect defective drugs prior to reaching patients. | 12 hours | October 28-29, 2026 | Durham, NC | Register today |
| Change Management | Learn how to develop comprehensive change management capabilities to successfully implement changes, from procedural revisions to facility modifications. Topics include regulatory requirements, overcoming barriers to change, change control processes, proper documentation and organizational strategies. In this interactive training, learn how to identify common pitfalls, assess risks and implement robust change control strategies, through real-world case studies, group activities and scenario-based exercises. Emphasis is placed on cross functional collaboration, documentation excellence and integration with quality management systems (QMS), including corrective and preventive actions (CAPA), deviations and supply chain considerations. Designed for professionals in quality assurance, quality control, operations, regulatory affairs and senior leadership. | 13.75 hours | November 17-18, 2026 | Seattle, WA | Register today |
| Process Validation | Learn the importance of ensuring control in the manufacturing process by aligning process validation activities with the drug lifecycle concept to produce quality drugs for patients. | 15 hours | November 30 – December 3, 2026 | Virtual | Register today |
| Environmental Monitoring | Learn how to develop an effective environmental monitoring program, including sample collection methods and contamination control practices, to comply with federal regulations and ensure drug quality and patient safety. | 15.25 hours | January 26-28, 2027 | College Station, TX | Register today |
| Cleanroom Design and Operation | Learn cleanroom design, operation and maintenance for sterile drug production. Conduct cleanroom performance tests for airflow velocity and uniformity, high-efficiency particulate air (HEPA) filter leaks and repairs and smoke studies. | 13.75 hours | February 9-11, 2027 | College Station, TX | Register today |
| Sterile Drug Compounding | Learn the fundamentals of sterile drug production by integrating aseptic processing, sterile filtration, cleanroom operations, facility cleaning and disinfection, aseptic process simulation (media fills) and environmental monitoring to ensure drug quality and patient safety. | 15.25 hours | February 23-25, 2027 | College Station, TX | Register today |