Executive Development Programme in Biopharma Compliance Systems
-- ViewingNowThe Executive Development Programme in Biopharma Compliance Systems is a certificate course designed to meet the growing industry demand for professionals with expertise in biopharma compliance. This programme emphasizes the importance of regulatory compliance in the biopharma industry and equips learners with essential skills to navigate the complex compliance landscape.
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⢠Introduction to Biopharma Compliance Systems: Regulatory frameworks, industry standards, and best practices
⢠Quality Management Systems (QMS): ISO 13485, ISO 9001, and FDA Quality System Regulation
⢠Good Manufacturing Practices (GMP): CGMPs, EU GMPs, and ICH Q10 guidelines
⢠Good Laboratory Practices (GLP): OECD series on principles of GLP and FDA GLP regulations
⢠Good Clinical Practices (GCP): ICH E6 guidelines, FDA GCP regulations, and EU GCP Directive
⢠Data Integrity: ALCOA+ principles, data governance, and data lifecycle management
⢠Risk Management: ISO 14971, ICH Q9, and FDA guidance on process validation
⢠Change Management: Change control, deviation management, and CAPA system
⢠Regulatory Inspections and Audits: Preparation, execution, and follow-up
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