The Center for Professional Advancement, New Brunswick, NJ
August 1-3, 2007
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 toQC 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 model procedures and assessment checklists.
Course Type: A Three Day Intensive Course
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