Compounding Quality Center of Excellence | Training Programs
FY22 Q4 Website Update
I. ILT Training Section
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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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 each course lasts a few hours. Click on the course names to complete the course and learn more about obtaining continuing education credits.
- Sterility 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.
- 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, 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.
- 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 CAPAs. Discover elements that trigger investigations, investigative tools, developing and implementing CAPAs, verifying effectiveness of CAPAs and initiating and completing investigations and CAPAs.
- Personnel 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 necessary techniques to minimize contaminating your gown or the aseptic environment.
- Supplier / Contractor Qualification and Management: Learn how to select, qualify, manage, and audit suppliers and contractors. Topics of 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 / contactor qualification and management lifecycles.
- Aseptic 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 include why integral media-filled units must be incubated and evaluate the need to thoroughly investigate failures and implement corrective actions.