The former "GLP/cGMP" Committee has changed its name to "Quality and Compliance" (QCC) to better reflect the breadth of issues we address. This change should also make it easier for non-regulated (ie non-GLP or cGMP) ABRF members to identify the functions of the Committee.
We are in progress with our next article, currently entitled "Laboratory Quality Measures and Analytical Method Validation". Sections include: "Elements of a `Quality' Laboratory"; "Differences Between Discovery, Development, and Disposition Testing"; "How to Demonstrate that Methods are Sound"; "Designing Validations to Meet Specific Objectives"; and "System Suitability Measures".
While the intended audience for this article is both core laboratory personnel and core laboratory clients, the focus is mainly on helping laboratory personnel understand the various aspects of quality and validation and how to implement them in everyday operations. Our goal is to expose a broad base of researchers and facilities to this information.
Additional QCC activities include accepting an invitation from the National Health Care Congress to present a seminar at their upcoming "Emerging Technologies for Biological Characterization" Symposium. The meeting, September 17-19 in Washington D.C., will highlight the application of various analytical technologies to the characterization of specified biomaterials as defined by the FDA in their recent final proposal on "well-characterized" biologicals. Representatives from the FDA and from industry will present their perspectives on characterization issues and potential analytical strategies. Nadine Ritter will represent ABRF and the QCC in presenting "Accessing Technologies via Analytical Laboratories: Evaluation of Laboratory Quality Practices". For information about the symposium, contact Carol Sussman at (617) 768-2572.
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