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Quality Control Material |
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Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft |
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Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236) |
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Quality Systems |
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FDA Launches Initiative to Improve the Development and Availability of Innovative Medical Products |
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GMP Information / Quality Systems Information |
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Guide to Inspections of Quality Systems (QSIT) |
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Guideline on General Principles of Process Validation |
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Improving Innovation in Medical Technology: Beyond 2002 |
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Improving Innovation in Medical Technology: Beyond 2002 - Executive Summary |
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Medical Device Manufacturer's Survey Evaluation of FDA Quality System / Good Manufacturing Practice Inspections |
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Medical Device Quality Systems Manual: A Small Entity Compliance Guide |
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Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation |
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Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff |
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Reengineering: Good Manufacturing Practices (GMP) Inspection Process |
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Schedule for GMP/QS Workshops with CDRH Participation |
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Y2K Issue for Production Processes and Quality System Software |
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