Executive Development Programme in Pharma Compliance & Risk Mitigation
-- ViewingNowThe Executive Development Programme in Pharma Compliance & Risk Mitigation is a certificate course designed to empower professionals with the necessary skills to navigate the complex regulatory landscape of the pharmaceutical industry. This programme is crucial in today's rapidly evolving pharmaceutical sector, where compliance and risk management have become paramount.
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⢠Introduction to Pharma Compliance & Risk Mitigation: Regulatory framework, compliance requirements, risk management strategies
⢠Pharmaceutical Quality Systems: Quality assurance, quality control, cGMP regulations
⢠Regulatory Affairs: FDA regulations, EMA guidelines, global harmonization
⢠Pharma Compliance in Clinical Trials: ICH-GCP, IND/CTA submissions, site management
⢠Pharmacovigilance & Drug Safety: ADR reporting, pharmacovigilance systems, risk management plans
⢠Supply Chain Management & Compliance: GDP regulations, supply chain security, distribution strategies
⢠Data Integrity & Compliance: ALCOA+ principles, data governance, auditing
⢠Risk Mitigation Strategies: Root cause analysis, corrective & preventive actions, continuous improvement
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