The Journal of GXP Compliance
Vol. 21, Issue 2, Mar 2017

Alan Schwartz
The Medical Device Single Audit Program (MDSAP) is a new medical device auditing plan with potential for several advantages. This discussion addresses an actual MDSAP audit experience and demonstrates how the organization dealt with its complexities. The MDSAP program is described including country involvements.
IVT Members receive access to the slides from Dr. Geoff Carr's comprehensive webinar called, Maintenance and Management of Stability Chambers." His presentation covered: I. Designs of Stability Chambers II. Conducting IQ/OQ/PCs III. Security of Stability Chambers IV. Dealing with Problems
Paul L. Pluta
Participants at a recent industry meeting describe various experiences they had with new management in their respective organizations. The contrasting management styles of the two managers and potential consequences are discussed.
Richard C. Wedlich
Agata E. Libera
Joseph M. Fransen
C. Tellarini
T. Heath
This discussion provides an overview of a CAPA program at a contract laboratory. Emphasis is on correctly identifying roles and responsibilities and showing how the program is an integral part of the laboratory operation.
Ivan Soto
This paper discusses the background, challenges, and strategies for data integrity in the QC laboratories, so that you can significantly reduce compliance risk when tackling FDA and MHRA guidance documents.
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