US DMF submissions (API)

Syllabus covers: Types of DMF, submission, review, communication letters

Category: Crash Courses
Duration : 90 minutes is the training duration, course would be accessible for 1 month from the date of taking admission

Learning objectives

The course is designed to understand types of USDMF, submission, various reviews conducted by the FDA and their outcomes, reference guidance, and interview questions on this topic.  

Eligibility

B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge.

Anyone willing to know this topic can enroll.

Syllabus

  • Section 1: US API DMF submissions & review
    • Types of DMF, submission, review 120 minutes
    • USDMF communication letters 20 minutes

Fees : 1983

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    Course Include :
  • Video
  • PDF
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