Global Certificate in Pharma Regulatory Compliance Strategies
-- ViewingNowThe Global Certificate in Pharma Regulatory Compliance Strategies is a comprehensive course that provides learners with critical skills in navigating the complex regulatory landscape of the pharmaceutical industry. This course is essential for professionals seeking to advance their careers in pharmaceutical compliance, as it covers the latest regulations, trends, and best practices in the field.
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⢠Global Pharma Regulations: Overview of global pharma regulations, including ICH, FDA, EMA, and WHO guidelines
⢠Quality Management Systems: Implementing and maintaining QMS in compliance with global pharma regulations
⢠Good Manufacturing Practices (GMPs): Understanding and applying cGMPs to ensure product quality and safety
⢠Pharmacovigilance: Monitoring, evaluating, and preventing adverse drug reactions and ensuring patient safety
⢠Clinical Trials Regulation: Compliance with ICH-GCP and regional regulations for clinical trials
⢠Regulatory Submissions: Preparing and submitting regulatory applications for new drugs and generics
⢠Labeling and Packaging: Ensuring compliance with global labeling and packaging requirements
⢠Regulatory Inspections and Audits: Preparing for and managing regulatory inspections and audits
⢠Risk Management: Implementing risk management strategies to ensure regulatory compliance and product quality
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