Description
This course will provide a solid overview of the principles and
technology of residue removal and residue measurement on
product contact surfaces. It will address the latest issues,
industry practices and compliance strategies regarding choice
of cleaning techniques, cleaning agents, analytical methods,
residue challenges, grouping strategies and validation
protocols. Examples of current industry cleaning validation
practices and case histories will be presented. Recent FDA
inspection history and regulatory comment regarding these
issues will be discussed in depth.<br><br>
This practical course will help participants familiar with this
topic to better evaluate and develop their own FDA regulated
cleaning programs that balance production objectives against
QA/validation objectives. The idea is to first achieve an
effective reliable cleaning process, then generate sufficient
data and justification without going overboard on the number
of samples, the number of analytical tests and the number of
qualification studies that have become an excessive burden
to many firms.<br><br>
Participants are encouraged to bring a cleaning problem to
the course for inclusion in the “Participant Problem Clinic” on
the second day.
