Professional Certificate in FDA Submission Preparation
-- ViewingNowThe Professional Certificate in FDA Submission Preparation is a comprehensive course that equips learners with the necessary skills to prepare and submit applications to the US Food and Drug Administration (FDA). This course is vital for professionals working in or seeking to enter the pharmaceutical, medical device, and biotech industries.
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⢠FDA Regulations and Guidelines
⢠Understanding FDA Submission Categories
⢠Preparing Quality Data for FDA Submissions
⢠Document Management for FDA Submissions
⢠eCTD (Electronic Common Technical Document) Structure
⢠FDA Submission Process and Timelines
⢠Ensuring Compliance with FDA Regulations
⢠Post-Submission Maintenance and Updates
⢠Addressing FDA Review Comments and Responses
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