Laboratory Control System
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Who Should Attend
This course is designed for those who are responsible for
performing laboratory work or managing a laboratory in
conformance to current good manufacturing practice (cGMP)
for pharmaceutical products. It will be of special interest to:-
QC Chemists
- Developmental Chemists
- Microbiologists
- Laboratory Supervisors
- Managers
- QA Record Reviewers and QA Auditors
Description
Laboratory Control has been the largest identifiable area of
cGMP observations of non-compliance during FDA
inspections for the past decade. Recently the FDA changed
its inspectional technique to focus on systems. The emphasis
of this seminar will be the Laboratory Control System
identified in the FDA Systems Inspection Program and the
relationship of the Laboratory Control System components to
the cGMPs (21CFR210 and 211) and FDA and ICH guidance
documents. Discussions include examples of investigational
observations. Discussions, workshops and course notes
include assessment checklists.