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Laboratory Developed Test Training Courses
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Manufactured by:Analytik Jena - an EndressHauser Company based inJena, GERMANY
The SARS-CoV-2 pandemic has shown how a rapid rise in demand for patient and community sample testing can quickly overwhelm testing capability globally. With most diagnostic infrastructure dependent on specialized instruments, their exclusive reagent supplies quickly become bottlenecks, creating an urgent need for approaches to boost testing capacity. Prof. Paul Freemont and colleagues at the ...
Organized by:International Society of Blood Transfusion (ISBT) based inAmsterdam, NETHERLANDS
Learn about the use of polyclonal and monoclonal antibodies in the laboratory, how they are produced, and the impact of human genetic variation on interpretation of blood bank tests. Polyclonal and monoclonal antibodies are widely used in blood bank laboratory testing. Learn about the origin of different reagent antibody types and their advantages and disadvantages. You will build understanding ...
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)
This comprehensive training package of 8 courses is aimed at helping medical device companies ensure that their supply chain controls and manufacturing processes comply with existing ...