Description
Although one of the most basic and long standing areas of
pharmaceutical and FDA regulated manufacturing, “cleaning,”
“sanitation,” or “environmental control” programs remain an
essential part of cGMP compliance with numerous issues and
potential problems such as effectiveness and safety of
chemical agents, sterility or cleanliness requirements for
supplies and cleaning tools, and methods selection and
proper techniques for sampling and measuring viables and
nonviables.<br><br>
It is an ironic but accepted problem in this field that one of the
major sources of contamination is the frequent sampling and
measurement of contamination required by cGMPs. It is felt
that, because the cleaning methods are predominantly
manual, they can not be fully “validated.” In addition to a
rigorous environmental monitoring program, worker technique
and training are critical factors in process reliability.<br><br>
This course will shed light on these important issues and offer
pragmatic help to overcome obstacles that often stand in the
way of consistent, cost effective, biodecontamination
programs. Just as important, the course will provide valuable
guidance on conforming to qualification and validation
requirements including disinfectants, facility conformance,
gowning and pass-through, environmental sampling plans,
data collection and reporting and response/action plans.
