Professional Certificate in Pharma Compliance Consulting
-- ViewingNowThe Professional Certificate in Pharma Compliance Consulting is a comprehensive course designed to meet the growing industry demand for experts in pharmaceutical compliance. This certificate course emphasizes the importance of adhering to laws, regulations, and industry standards, ensuring the safety and efficacy of pharmaceutical products.
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โข Introduction to Pharma Compliance Consulting: Understanding the regulatory landscape, role of a compliance consultant, and best practices
โข Regulatory Frameworks: FDA, EMA, and ICH guidelines, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP)
โข Risk Management: Identifying, assessing, and mitigating risks in pharmaceutical manufacturing and clinical trials
โข Quality Assurance & Control: Quality systems, documentation, and data integrity
โข Pharmacovigilance: Adverse event reporting, signal detection, and risk management plans
โข Clinical Trial Compliance: Informed consent, institutional review boards (IRBs), and data management
โข Compliance Training: Designing, implementing, and assessing effective training programs
โข Audits & Inspections: Preparing for and managing internal, external, and regulatory audits and inspections
โข Corrective & Preventive Actions (CAPA): Investigating, documenting, and implementing CAPAs
โข Ethics in Pharma Compliance Consulting: Maintaining integrity, confidentiality, and objectivity
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