Professional Certificate in Combination Product Import/Export Laws
-- ViewingNowThe Professional Certificate in Combination Product Import/Export Laws is a crucial course for professionals dealing with pharmaceutical, medical device, and biologic products. This program covers essential regulations and guidelines, such as FDA, EU MDR, and MDD, ensuring learners can navigate the complex landscape of combination product laws.
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โข Introduction to Combination Product Import/Export Laws
โข Understanding Regulatory Bodies: FDA, EU, and others
โข Import/Export Processes and Procedures
โข Combination Product Classification and Categorization
โข Labeling, Documentation, and Record Keeping Requirements
โข Quality System Requirements and Compliance
โข Import/Export Challenges and Risk Management
โข Enforcement, Penalties, and Legal Considerations
โข Strategies for Successful Combination Product Import/Export
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