Aseptic Competency Mapping

A well-designed competency-based aseptic competency program addresses many business performance issues, including:

  • Reduce work stoppages, compromised product sterility and other failures
  • Mitigate risk exposure from FDA observations
  • Minimize allocation of time, money, and human resources for CAPAs 
  • Improve performance, productivity, and quality for competitive advantage
  • Raise workforce morale and motivate the pursuit of excellence
  • Simplify life for everyone from the shop  floor to the executive floor

As a skills development exercise, competency mapping is one of the most accurate means of identifying the job and behavioral competencies of an individual in an organization.

Forward facing pharmaceutical companies engaged in aseptic processing operations should consider UL's “Seven Steps”  example to map relevant, competency-based actions that need to be conducted for each job function.

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Associated programs

Corporate Compliance - Plan Sponsors Program

Aseptic Processing

Our Aseptic Processing Basics series introduces core concepts of aseptic behavior and sterile manufacturing topics, enabling GMP Trainers and Operation Development Teams to address core requirements -- and introduce standards such as ICH Q9 and ISO 14644.

5 courses

Resources