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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⢠Global GMP Regulations: Overview of international GMP standards, including ICH Q7, EU GMP, PIC/S, and WHO GMP
⢠Quality Management System (QMS): Design, implementation, and maintenance of an effective QMS according to ISO 9001:2015
⢠Good Documentation Practices (GDP): Principles and techniques for creating, reviewing, approving, and storing GMP-compliant documents
⢠Risk Management in GMP: Implementation of risk management tools and techniques, such as FMEA and HACCP, in compliance with GMP
⢠Facility and Equipment Design and Qualification: Design, construction, and qualification of GMP-compliant facilities and equipment
⢠Material Management and Supply Chain: Procurement, storage, and distribution of raw materials, intermediates, and finished products
⢠Production Processes and Controls: Design, optimization, and monitoring of manufacturing processes and in-process controls
⢠Quality Control and Laboratory Practices: Validation, qualification, and operation of analytical methods and laboratory controls
⢠Personnel Training and Competence: Design, implementation, and assessment of GMP-compliant training programs
⢠Change Management and Deviation Handling: Management of changes and deviations in a GMP-compliant environment
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