Regulatory agencies, notified bodies, and standards organisations around the world have similar requirements for those involved in producing and controlling products used in healthcare.
These requirements for personnel include:
However, the guidance does not provide a specific definition for skills, knowledge, experience and competency.
The SfSAP addresses this issue by bringing together panels of recognized international experts to follow a standard approach for defining and demonstrating competency, which enables the medical device and pharmaceutical industries to meet the necessary requirements.
Access our comprehensive guides and learning materials by becoming a member of SfSAP:
The Society for Sterility Assurance Professionals has been established as a collaborative not-for-profit initiative by the iia, AAMI and PDA. It aims to enable the medical device and pharmaceutical industries to formulate a standard approach to meeting the requirements listed below, and establish pathways for individual career growth.
Regulatory documentation for Sterility Assurance Professionals:
The SfSAP is comprised of several Working Groups, each focused on a specific area of interest. Each working group is led by a Chair who reports to the Steering Committee, which oversees and directs the activities of the SfSAP. The SfSAP Board provides formal structure to the organization, and is responsible for managing financial affairs and ensuring legal compliance.
The Society for Sterility Assurance Professionals (SfSAP) is a professional association that is dedicated to the advancement of sterility assurance for medical and pharmaceutical products. The founding principles of the SfSAP are:
To establish the required level of knowledge, understanding and experience to demonstrate competency based on the individuals’ role in the sterilization lifecycle.
To encourage better coordination in the training, testing and development of Sterility Assurance professionals through a competency framework.
To support individuals in achieving their development goals and the needs of the healthcare community in the field of Sterility Assurance.
To enable members of the community to build networks in order to achieve their career development goals and the needs of the wider healthcare community.
To create a career pathway for those involved in the sterility assurance and the sterilisation lifecycle of medical and pharmaceutical products.