Compounding Quality Center of Excellence | Training Programs
FY22 Q4 Website Update
I. ILT Training Section Virtual, Instructor-Led Trainings
Virtual, Instructor-Led Trainings
The Center of Excellence’s free virtual interactive trainings with live instruction are available to outsourcing facilities with limited space for traditional compounders and regulators. These multi-day trainings are offered on a limited basis and provide continuing education credits. Early registration is recommended.
Training Schedule and Information
The following virtual and instructor-led trainings are being offered in 2022 and 2023, and are recommended for:
- pharmacists
- pharmacy technicians
- laboratory staff
- quality staff, including quality control, quality assurance
- operations, production or manufacturing
- microbiologists
- management
Click on the course names to request registration.
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Course Overview |
Dates |
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Quality Management Systems: Learn the fundamentals of establishing an effective Quality Management System (QMS) and building a culture of quality within a facility. This course includes information about the comprehensive QMS approach to quality, the critical role of senior leadership, and building a quality culture mindset throughout the organization. The course will also explore the concepts of knowledge management, quality risk management, and data integrity. Practical activities will include the use of case studies, responding to inspectional observations and warning letters, conducting quality culture assessments, and evaluating data integrity risks. |
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Sterile Drug Compounding: Learn the basic principles, processes, and systems related to sterile drug production. The course integrates principles of aseptic processing, sterile filtration, cleanroom operations, facility cleaning and disinfection, aseptic process simulation (media fills), and environmental monitoring – all within the context of regulatory expectations. |
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Environmental Monitoring: Learn how to develop an environmental monitoring program and various sample collection methods through a combined teaching approach of lecture and practical activities. |
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Investigations and Corrective and Preventative Actions (CAPA): Discover science-based methodology integrating problem solving techniques from total quality management (TQM), Six Sigma, Kaizen, and other techniques to identify the technical root causes, systemic root causes, corrective and/or preventive actions and a control plan for preventing recurrence. |
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Process Validation: Learn general principles and approaches of Process Validation and the importance of ensuring control in the manufacturing process to produce consistent, quality products for patients. This introductory course aligns process validation activities with a product lifecycle concept and existing FDA guidance documents for industry, including Process Validation: General Principles and Practices and the following FDA/International Council on Harmonisation (ICH) guidelines: Q8(R2), Pharmaceutical Development; Q9, Quality Risk Management; and Q10, Pharmaceutical Quality System, all developed to ensure product quality. |
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| Cleanroom: Learn through practical activities to highlight cleanroom performance tests such as airflow velocity and uniformity, high-efficiency particulate air (HEPA) filter leak testing and repairs and airflow visualization smoke studies. |
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II. Self-Guided Online Trainings
The Compounding Quality Center of Excellence offers free, self-guided online trainings that are available to anyone. Participants can complete these courses at their own pace and obtain continuing education credits.
Take Self-Guided Online Trainings
Courses offered include:
- Sterility Testing: Common Misconceptions
- Regulatory Framework for Human Drug Compounding
- Airflow
- Insanitary Conditions and Sterility Assurance
- Stability and Beyond Use Dates
- Outsourcing Facility Guide
- Investigations and Corrective and Preventive Actions (CAPA)
- Personnel Gowning in Sterile Drug Production
- Supplier / Contractor Qualification and Management
- Aseptic Process Simulations (Media Fills)