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Objectives:
- Increase awareness of Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals as they apply to Medical Gas Industry
- Ensure Medical Gas Industry takes appropriate action to establish effective controls, thus preventing regulatory problems when inspections occur
- Provide working knowledge to FDA investigators to integrate in day-to-day inspections
- Provide the same regulatory message, at the same time, to FDA and state regulators, and medical gas industry
Target Audience:
- Medical Gas Industry
- State regulators of medical gas industry
- FDA regulators of medical gas industry: investigators, supervisors, compliance officers