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Regulatory

Overview of Standardization & Validation in Clinical Laboratories (USA only)

 

Save yourself many hours of research and reading! Get the insides you need by viewing this video presentation. Get access to material that cannot be found anywhere else.

You get an 1½h Video Presentation on DVD and the Presentation Transcript.

Do you want to know:  “What role the FDA plays when it comes to the use of Digital Pathology in a clinical laboratory?” or “What are the latest thoughts in the industry on the validation of Digital Pathology systems?” Find the answers here.

This comprehensive overview is provided by Dr. Holger Lange, CTO Flagship Biosciences L.L.C., and covers the following subjects:

Clinical Laboratory Regulations

A discussion on how the CLIA standard and the CAP checklist apply to Digital Pathology. A review of the new ASCO/CAP guidelines for HER2 and ER/PgR for the latest thoughts on standardization and validation in clinical laboratories.

Medical Device Manufacturer Regulations

An overview of the existing US Food and Drug Administration (FDA) clearances for Digital Pathology with an example of a successful study design. A discussion on the FDA advisory panel meeting on Digital Pathology Whole Slide Imaging (WSI) for the latest thoughts on what it takes to validate Digital Pathology systems for primary diagnosis.

Digital Pathology Systems

Practical tips on how to implement a digital pathology system in a clinical laboratory and how digital pathology manufacturers could make it easier. A demo of how a digital pathology system can help with the logistics of its own validation. Discussion on how going digital could be a game changer for the standardization of pathology, looking at the example of the automatic standardization of staining using standard controls and automatic image analysis.

SPECIAL OFFER until 12/31/2011
with our Feature Article in LabMedicine October 2011

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