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:
- Education, training, and experience or a combination of these to enable persons to perform safely, effectively, and compliantly
- Refresher training that contribute to their continued competence
- Participating in learning events to stay current with issues, changing requirements
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:
WHO DO WE HELP?
- Sterility assurance professionals
- Pharmaceutical and healthcare manufacturers
- Contract sterilisers
- Industry associations
- Standards development organisations
- Special interest groups
- Education Delivery Organisations (EDOs)
- Health authorities, regulatory bodies
Understanding the 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:
- Medical Device Regulations (MDR), ISO 13485:2016
- FDA Code Of Federal regulations 21 CFR
- Medical Device Single Audit Program (MDSAP) G0002.1004
- Canada Health Good manufacturing practices guide for drug products GUI-0001
- EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part 1
- World Health Organization (WHO) guide to good manufacturing practices (GMP) requirements Part 3 Training
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.
SfSAP Founding Principles
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:
Competency
To establish the required level of knowledge, understanding and experience to demonstrate competency based on the individuals’ role in the sterilization lifecycle.
Collaboration
To encourage better coordination in the training, testing and development of Sterility Assurance professionals through a competency framework.
Community
To support individuals in achieving their development goals and the needs of the healthcare community in the field of Sterility Assurance.
Connection
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.
Career
To create a career pathway for those involved in the sterility assurance and the sterilisation lifecycle of medical and pharmaceutical products.