Description
<strong>Course Schedule - 10-14 November 2008</strong><br/><br/>This course provides an understanding of the principles and
practice of pharmaceutical quality assurance and control and
of specific topics which have become important because of
regulatory interest or recent technological achievements.
Throughout the course an emphasis is placed upon quality as
viewed on a cost/benefit basis as well as a cGMP basis.<br><br>
The first day provides an understanding of the basic principles
and practice of the QA and QC functions, covering their role
during product design, production and revision, with the role
in production being dealt with in particular detail. The second,
third and fourth days consist of reviews, first of broad current
quality issues including FDA activities, and then the QA/QC
aspects of a number of specific issues including: quality risk
management, handling of laboratory controls, validation
(equipment, processes, computers, cleaning and test
methods), label and labeling, water systems, change control,
electronic records and signatures, deviations and
discrepancies, (including OOSs), FDA inspections, internal
and supplier audits, vendor and contract supplier qualification,
annual product reviews, and training. A general question and
answer session is also provided. The fifth day is devoted to
the QA/QC aspects of stability program operation, and also
to documentation. The course includes hands-on workshops
as well as lectures.
