Certificate in Combination Product Distribution Management
-- ViewingNowThe Certificate in Combination Product Distribution Management is a comprehensive course designed to meet the growing industry demand for experts in combination product distribution. This certificate equips learners with essential skills necessary for career advancement in pharmaceutical, biotech, and medical device industries.
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⢠Combination Product Regulations: Understanding FDA regulations for combination products, including definitions, categories, and requirements for distribution.
⢠Quality Management Systems: Implementing and maintaining QMS for combination products, including quality assurance, document control, and corrective and preventive action.
⢠Good Distribution Practices: Adhering to GDPs for combination products, including storage, transportation, and record-keeping requirements.
⢠Supply Chain Management: Managing the supply chain for combination products, including supplier selection, evaluation, and monitoring.
⢠Sterilization and Validation: Understanding the sterilization methods and validation requirements for combination products.
⢠Labeling and Packaging: Ensuring proper labeling and packaging of combination products, including UDI requirements and instructions for use.
⢠Recall Management: Developing and implementing recall management plans for combination products, including product tracking and reporting requirements.
⢠Complaint Handling: Managing complaint handling processes for combination products, including reporting requirements and root cause analysis.
⢠Risk Management: Implementing risk management strategies for combination products, including hazard analysis and critical control points (HACCP).
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