The art of compliance is a craft much like that of a carpenter who learns to
work with various kinds of wood and designs. Ours is an industry wrought
with differences. While the regulations that govern FDA-regulated industries
are proscribed, how the regulations are interpreted and applied really
depends on experience and how well one has mastered the craft of compliance.
There are no proscribed procedures, but there are guideposts common
to all FDA-regulated industries, whether a firm manufactures medical
devices, pharmaceuticals, or biological products....
A soft ground condition exists whenever construction loads a cohesive foundation soil beyond its preconsolidation
stress, as often occurs with saturated clays and silts having SPT blow counts that are near zero. The paper
recommends testing programs, testing methods and data interpretation techniques for developing design
parameters for settlement and stability analyses. It hopes to move the state-of-practice closer to the state-of-the-art
and thus is intended for geotechnical practitioners and teachers rather than researchers.
The PLAXIS 2D program is a special purpose two-dimensional finite element program
used to perform deformation and stability analysis for various types of geotechnical
applications. Real situations may be modelled either by a plane strain or an axisymmetric
model. The program uses a convenient graphical user interface that enables users to
quickly generate a geometry model and finite element mesh based on a representative
vertical cross section of the situation at hand. Users need to be familiar with the Windows