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  1. Human Drug Compounding

Compounding Quality Center of Excellence: In-Person Training Programs

The Compounding Quality Center of Excellence’s in-person training programs target outsourcing facility staff and offer continuing education credits. The training will open for state regulators and pharmacy compounders if space is available.

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

  • Environmental Monitoring: Learn how to develop an environmental monitoring program and various sample collection methods through a combined teaching approach of laboratory-based and classroom methods.
     
  • Sterile Drug Compounding: Learn the basic principles, processes and systems related to aseptic processing. The course integrates environmental monitoring systems, facility cleaning and disinfection, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation and media fill – all within the context of regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, performing aseptic processes in ISO 5 conditions and performing a visual inspection.
     
  • Cleanroom: Learn through hands-on, practical demonstrations at a facility with four cleanrooms/zones 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): 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. Outsourcing facilities may send two personnel to this course.

 

Training Schedule and Information

Course Name

Dates

Course Length

Location

Intended Audience

Environmental Monitoring

  • March 3 – 6
  • May 26 – 29
  • June 29 – July 2
  • July 28 – 31
  • August 24 - 27

4 Days

Bethesda, MD

  • Supervising pharmacist or non-pharmacist manager equivalent
  • Facility manager
  • Quality control engineer
  • Infection control lead

Sterile Drug Compounding

  • March 9 – 12
  • May 18 – 21
  • June 8 – 11
  • August 3 – 6

4 Days

Bethesda, MD

  • Supervising pharmacist or non-pharmacist manager equivalent

Cleanroom

  • May 12 – 14
  • June 16 – 18
  • July 14 – 16
  • August 11 – 13

3 Days

Bethlehem, PA

  • 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

Bethesda, MD

  • Quality control lead or manager equivalent
  • Process improvement lead or manager equivalent