Global Certificate in GMP: International Standards
-- ViewingNowThe Global Certificate in GMP: International Standards is a crucial course for professionals seeking to excel in the pharmaceutical and healthcare industries. This certificate program focuses on Good Manufacturing Practices (GMP), which are essential for ensuring the quality and safety of pharmaceutical products worldwide.
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โข Global GMP Regulations: Overview of international GMP standards, including ICH Q7, EU GMP, PIC/S, and WHO GMP
โข Quality Management System (QMS): Design, implementation, and maintenance of an effective QMS according to ISO 9001:2015
โข Good Documentation Practices (GDP): Principles and techniques for creating, reviewing, approving, and storing GMP-compliant documents
โข Risk Management in GMP: Implementation of risk management tools and techniques, such as FMEA and HACCP, in compliance with GMP
โข Facility and Equipment Design and Qualification: Design, construction, and qualification of GMP-compliant facilities and equipment
โข Material Management and Supply Chain: Procurement, storage, and distribution of raw materials, intermediates, and finished products
โข Production Processes and Controls: Design, optimization, and monitoring of manufacturing processes and in-process controls
โข Quality Control and Laboratory Practices: Validation, qualification, and operation of analytical methods and laboratory controls
โข Personnel Training and Competence: Design, implementation, and assessment of GMP-compliant training programs
โข Change Management and Deviation Handling: Management of changes and deviations in a GMP-compliant environment
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