Graduate Certificate in Compliance and QA in Pharma
-- ViewingNowThe Graduate Certificate in Compliance and QA in Pharma is a comprehensive course designed to meet the growing industry demand for professionals with expertise in compliance and quality assurance. This certificate program equips learners with critical skills necessary to ensure adherence to regulatory standards, maintain quality control, and drive continuous improvement in pharmaceutical production and distribution.
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โข Regulatory Compliance in Pharma: Understanding FDA regulations, ICH guidelines, and other global pharma compliance requirements
โข Quality Assurance (QA) Principles: Implementing QA systems, GMP (Good Manufacturing Practices) compliance, and quality risk management
โข Pharmacovigilance: Adverse event reporting, pharmacovigilance systems, and pharmacoepidemiology
โข Clinical Trials Compliance: ICH-GCP (Good Clinical Practice) guidelines, informed consent, and clinical trial monitoring
โข Data Integrity in Pharma: Data governance, data life cycle management, and ALCOA+ principles
โข Quality Control (QC) Strategies: Quality control tools, statistical process control, and SOPs (Standard Operating Procedures)
โข Auditing and Inspection Readiness: Conducting internal audits, mock inspections, and responding to regulatory authority inspections
โข Pharma Supply Chain Management: GDP (Good Distribution Practices), supply chain security, and cold chain management
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