Objectives:

- Define the term, “expert”
- Provide examples of health authority requirements
- Discuss the ways expertise can be acquired

- Present the SfSAP’s learning frameworks, specifically for those involved in irradiation

Details:

Having personnel with the requisite knowledge and skills is required not only by manufacturing, processing, and testing facilities for successful outcomes but also by health authorities.  A recent “Interpretation” of the European Medicines Agency Guideline on Sterile Medicine document written by the Swiss health authority, SwissMedic, provides some information on what could establish one’s expertise but gives no details.  A recently established professional organization, the Society for Sterility Assurance Professionals (SfSAP) has worked with industry leaders to create learning frameworks with specific knowledge, skills, and experiences that would be needed for those involved in different modalities of sterilization including irradiation and aseptic processing.  This presentation describes how SfSAP developed their frameworks and how individuals, organizations, and health authorities can use these free resources

Conclusion:

SfSAP learning frameworks can be used by individuals and organizations, and health authorities as a pathway to develop expertise in those involved in assuring the sterility of pharmaceuticals, medical devices, and single-use systems..