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In Vitro Training Courses
3 training items found
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 ...
by:COBBLESTONE, a Division of The Center for Professional Advancement (CfPA) based inEast Brunswick, NEW JERSEY (USA)
In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. 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 ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
Medical devices cannot be shipped to Europe unless they are in full compliance with the European Medical Device Directive (MDD). The compliance requirements vary, depending on the classification of the device. It's not just the CE marking requirements that manufacturers and exporters have to worry about, but also the way the MDD is linked to the EU Clinical Trial Directive and ISO Certification ...