Post approval changes to ANDA

Syllabus covers: Change control concept, Changes to DMF & ANDA, PAS, CBE-30, CBE-0, Annual reports

Category: Crash Courses
Duration : 1 hour 25 minutes, course would be accessible for 1 month from the date of admission

Learning objectives

Change control: procedure, regulatory impact, Changes to DMF & ANDA, Classification of changes: PAS, CBE-30, CBE-0, Annual report

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 understand this topic can enroll.

Syllabus

  • Section 1:
    • Change control, Changes to DMF & ANDA, PAS, CBE-30, CBE-0, Annual reports 85 minutes

Fees : 1133

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    Course Include :
  • Video
  • PDF
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