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
- Microbiologists
- Managers
- QA Auditors
- Developmental Chemists
- Laboratory Supervisors
- QA Record Reviewers
Description
Laboratory Control has been the largest identifiable area of
cGMP observations of non-compliance during FDA inspections
for the past decade. In 2001 the FDA changed its inspectional
technique to focus on systems. More recently, the FDA and the
ICH have published guidance documents that encourage the
industry to establish Quality 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), ISO 17025 and FDA and ICH guidance
documents. Discussions include examples of investigational
observations. Discussions, workshops and course notes include
assessment checklists.