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Medical Devices Training Courses In Usa New Jersey
2 training items found
by:COBBLESTONE, a Division of The Center for Professional Advancement (CfPA) based inEast Brunswick, NEW JERSEY (USA)
One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of products must manufacture products that meet defined specifications. Developing processes that are adequate to produce medical devices or other products that requires a defined Sterility Assurance ...
by:COBBLESTONE, a Division of The Center for Professional Advancement (CfPA) based inEast Brunswick, NEW JERSEY (USA)
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that ...