Transcription of Production and Process Controls
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Production and Process Controls
Quality Production Laboratory Materials Facilities and Equipment Packaging and LabelingRegulatory Educationfor Industry (REdI):Focus on CGMPs & FDA InspectionsSheraton | Silver Spring, MD | July 15-16, 2015 Production and Process Controls :Overview of CGMP Regulations and Regulatory ExpectationsPresenters:VibhakarShah, , Consumer Safety OfficerOffice of Policy for Pharmaceutical Quality, OPQ, CDERV inayakPawar, , Senior Review MicrobiologistOffice of Process and Facility Assessment, OPQ, CDERQ uality Production Laboratory Materials Facilities and Equipment Packaging and LabelingThe Six Components Quality Production Laboratory Materials Facilities & Equipment Packaging & Labeling2 Quality Production Laboratory Materials Facilities and Equipment Packaging and LabelingOverview Public Health and product Quality Expectations Pharmaceutical Manufacturing Operation Production Relevant CGMP Regulations Regulatory Tools for Compliance Regulatory Expectations Summary QuestionsQuality Production Laboratory Materials Facilities and Equipment Packaging and LabelingPublic Health -ExpectationsPublic Health Care System -Stakeholders Patients/Consumers Expects reliable access to safe, efficacio
Production and Process Controls: Overview of CGMP Regulations and Regulatory Expectations Presenters: Vibhakar Shah, Ph.D., Consumer Safety Officer ... shall be consistent with drug product final ...
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