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Journal of Validation Technology ®
February 2006, Volume 12, Number 2 |
Table of Contents
BENCHMARKING: Questions presented for discussion and reader responses
Compiled Author: Paul Pluta, Ph.D.
The Concept Of Establishing A Compliance Master Plan (CMP)
Author: Robert A. Nash, Ph.D.
Application of Design of Experiment (DOE) Techniques to Process Validation
in Medical Device Manufacture
Authors: Dr. D. Dixon, Dr. J. Eatock, Prof. B.J. Meenan, and M. Morgan
The Effects of New Regulatory Initiatives on Process Validation
Author: Tim Fields
Regulatory and Validation Considerations for Aseptic Processes
Author: David W. Vincent
Temperature Mapping
Author: Francis S. Fernandes
Evaluating Average, Population, and Individual Bioequivalence in Nonlinear
Regression Model with Statistically Validating Software
Author: Laszlo Lugosi, MD, Ph.D., DSc. and Imre Molnar, BSc.