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 standards for good testing laboratory management, with a focus on FDA regulated industries. It will be of special interest to:
• Quality Control Analysts
• Microbiologists
• Managers
• Developmental Chemists
• Laboratory Supervisors
• Quality Assurance Record
Reviewers and Auditors
Description
Laboratory Control has been the largest identifiable area of cGMP observations of non-compliance during FDA inspections for a number of years. In 2001 the FDA changed its inspectional technique to focus on systems. More recently the FDA has been emphasizing Quality Systems. The emphasis of this course will be the Laboratory Control System identified in ISO 17025 and the FDA Systems Inspection Program and the relationship of the Laboratory Control System components to the cGMPs (21CFR 210 and 211) and other guidance documents. Discussions include examples of investigational observations.