Global Certificate in Biopharma Compliance & Ethics
-- ViewingNowThe Global Certificate in Biopharma Compliance & Ethics course is a vital certification for professionals seeking to excel in the biopharmaceutical industry. This course addresses the growing need for expertise in compliance and ethics, which are crucial in ensuring that companies adhere to regulations and maintain a strong reputation.
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โข Global Regulatory Landscape: An overview of international regulations and guidelines governing the biopharma industry, including FDA, EMA, and ICH.
โข Quality Management Systems: Best practices for implementing and maintaining a QMS in compliance with global standards, such as ISO 13485 and 21 CFR Part 820.
โข Good Clinical Practices: Understanding GCPs and their role in clinical trials, including site management, informed consent, and data management.
โข Good Manufacturing Practices: An exploration of GMPs, including cGMPs, and their impact on biopharma manufacturing, including documentation, change control, and deviations.
โข Pharmacovigilance and Risk Management: Strategies for monitoring, reporting, and managing adverse events and product risks to ensure patient safety and regulatory compliance.
โข Data Integrity and Management: Best practices for ensuring data integrity and compliance in biopharma, including data governance, security, and audit trails.
โข Supply Chain Management and Distribution: Understanding global supply chain regulations and best practices for distribution, including temperature control, tracking, and recall procedures.
โข Ethics in Biopharma: Exploring ethical considerations in the biopharma industry, including conflicts of interest, patient privacy, and research integrity.
โข Inspection Readiness and Response: Preparing for and responding to regulatory inspections, including mock inspections, root cause analysis, and corrective actions.
Note: This list is not exhaustive and may vary based on the specific needs and goals of the certification program.
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