Masterclass Certificate in GMP Inspections Preparation
-- ViewingNowThe Masterclass Certificate in GMP Inspections Preparation is a comprehensive course designed to equip learners with critical skills in Good Manufacturing Practice (GMP) inspections. This certification program is essential for professionals involved in pharmaceutical, biotech, and medical device manufacturing, where GMP compliance is paramount.
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โข GMP Fundamentals: An overview of Good Manufacturing Practices (GMP) and their importance in pharmaceutical manufacturing. This unit covers the basic principles of GMP, including documentation, change control, and deviations. โข Regulatory Framework: An understanding of the regulatory agencies and their roles in GMP inspections. This unit covers the FDA, EMA, and other international regulatory bodies. โข Quality Management System (QMS): An overview of the components and implementation of a Quality Management System, including quality assurance, quality control, and continuous improvement. โข Mock Inspection Preparation: A guide to preparing for a GMP inspection, including internal audits, risk assessments, and mock inspections. โข Critical Processes and Equipment: An understanding of the critical processes and equipment in pharmaceutical manufacturing, including validation, maintenance, and calibration. โข Documentation and Record Keeping: Best practices for documentation and record-keeping, including data integrity, electronic records, and archiving. โข Handling Deviations and Investigations: A guide to handling deviations and investigations, including root cause analysis, corrective and preventive actions (CAPA), and trending. โข Change Management: An overview of change management, including change control, impact assessment, and implementation. โข Corrective and Preventive Actions (CAPA): An understanding of CAPA, including the identification, investigation, and resolution of non-conformities. โข Management Responsibility and Commitment: An overview of the role of management in GMP compliance, including leadership, accountability, and continuous improvement.
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