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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⢠Introduction to Combination Product Import/Export Laws
⢠Understanding Regulatory Bodies: FDA, EU, and others
⢠Import/Export Processes and Procedures
⢠Combination Product Classification and Categorization
⢠Labeling, Documentation, and Record Keeping Requirements
⢠Quality System Requirements and Compliance
⢠Import/Export Challenges and Risk Management
⢠Enforcement, Penalties, and Legal Considerations
⢠Strategies for Successful Combination Product Import/Export
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