Certificate in Compliance Essentials for Pharma
-- ViewingNowThe Certificate in Compliance Essentials for Pharma is a comprehensive course designed to meet the growing industry demand for compliance professionals. This course emphasizes the importance of compliance in the pharmaceutical sector and equips learners with essential skills to navigate the complex regulatory landscape.
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โข Introduction to Pharma Compliance: Regulatory framework, compliance roles and responsibilities, penalties for non-compliance
โข Pharma Laws and Regulations: FDA, EMA, and other global regulations, GxP, cGMP, cGLP, cGDP
โข Quality Management System (QMS): ISO 13485, ISO 9001, quality manual, quality policy, quality objectives
โข Pharma Supply Chain Management: GDP, supplier qualification, vendor management, distribution channels
โข Pharmacovigilance: Adverse event reporting, signal detection, risk management, pharmacovigilance system master file (PSMF)
โข Clinical Trial Compliance: ICH-GCP, institutional review boards (IRBs), informed consent, clinical trial agreements
โข Data Integrity and IT Compliance: ALCOA+, computer system validation (CSV), data backup and recovery
โข Regulatory Inspections and Audits: Preparation, handling, and follow-up
โข Compliance Training and Communication: Training needs assessment, training plan, training records, communication strategy
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