Compounding Quality Center of Excellence: Virtual, Interactive Training Programs

The Compounding Quality Center of Excellence’s virtual, interactive training programs with live instruction target outsourcing facility staff and offer continuing education credits. Training will open for state regulators and pharmacy compounders if space is available.

Registration is free for participants for one offering of the course. Space is limited so early registration is recommended. The courses are:

• Environmental MonitoringExternal Link Disclaimer: Learn how to develop an environmental monitoring program and various sample collection methods through a combined teaching approach of lecture and practical activities.
• Sterile Drug CompoundingExternal Link Disclaimer: Learn the basic principles, processes and systems related to aseptic processing. The course integrates facility cleaning and disinfection, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation and media fill – all within the context of regulatory requirements. Practical activities will include gowning qualification, facility cleaning and disinfection, aseptic processes in ISO 5 conditions and visual inspection.
• CleanroomExternal Link Disclaimer: 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. 
• Investigations and Corrective and Preventive Actions (CAPA)External Link Disclaimer: Discover science-based methodology integrating problem solving techniques from total quality management, six sigma, kaizen, define, measure, analyze, improve, control, as well as other techniques to identify the technical root cause(s), systemic root cause(s), corrective and/or preventive actions, and a control plan for preventing recurrence.

Training Schedule and Information

Course Name	Dates	Course Length	Intended Audience
Environmental Monitoring	March 3 – 6 June 29 – July 2 July 28 – 31 August 24 - 27	4 Days	Supervising pharmacist or non-pharmacist manager equivalent Facility manager Quality control engineer Infection control lead
Sterile Drug Compounding	March 9 – 12 June 8 – 11 August 3 – 6	4 Days	Supervising pharmacist or non-pharmacist manager equivalent
Cleanroom	June 16 – 18 July 14 – 16 August 11 – 13	3 Days	Supervising pharmacist or non-pharmacist manager equivalent
Investigations and Corrective and Preventive Actions (CAPA)	July 8 – 10 July 29 – 31 August 31 – September 2	3 Days	Quality control lead or manager equivalent Process improvement lead or manager equivalent

 https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence-virtual-interactive-training-programs