Certificate Biopharma Regulatory Compliance
-- ViewingNowThe Certificate in Biopharma Regulatory Compliance course is a comprehensive program designed to provide learners with the essential skills needed to succeed in the highly regulated biopharma industry. This course covers critical topics such as GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and GCP (Good Clinical Practices).
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⢠Regulatory Framework: Understanding FDA, EMA, and other global regulatory bodies, their roles, and requirements
⢠Good Manufacturing Practices (GMPs): Learning the guidelines for manufacturing, testing, and packaging of pharmaceutical products
⢠Quality Systems: Implementing and maintaining Quality Management Systems, including Quality Assurance and Quality Control
⢠Documentation and Record Keeping: Managing SOPs, batch records, deviations, and change controls to ensure regulatory compliance
⢠Regulatory Intelligence: Monitoring, analyzing, and applying regulatory updates, guidelines, and trends
⢠Clinical Trials: Adhering to regulations and guidelines for planning, conducting, and reporting clinical trials
⢠Pharmacovigilance: Implementing and managing safety monitoring systems, adverse event reporting, and pharmacoepidemiology
⢠Regulatory Submissions: Preparing, reviewing, and submitting applications, including IND, NDA, and BLA, to regulatory agencies
⢠Inspection Readiness: Preparing for and managing regulatory inspections and responding to 483s and warning letters
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