Course offering number:1005-403
Course ID:
1867
Critical Process Cleaning and Cleaning Validation
26-28 May 2010
Amsterdam, The Netherlands
Who Should Attend
This course is intended for professionals in:
• Process Engineering
• Production
• Quality Assurance
• Validation
• Technical and management positions
You should have some familiarity and experience with the
basic subject as it applies to research and manufacturing of
pharmaceuticals, personal care products, nutritional materials
and fine chemicals.
Description
This course will provide a solid overview of the principles and
practices 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 and case histories will be presented.
Recent regulatory expectations and guidance from US and
Europe will be discussed in depth.
For participants experienced on this subject, this practical
course will help to better audit, evaluate and develop their
own or third party cleaning programs to balance production
objectives against QA/validation objectives. The idea is to
first achieve an effective, reliable cleaning process defined
parametrically, then generate sufficient data 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.
Participants are encouraged to bring a cleaning problem to
the course for evaluation by participant teams or for inclusion
in “Participant Problem Clinic” on the second day.