DMF preparation Module 3 [reference ICH CTD guidance]

Regulatory affairs professionals play a very crucial role by giving advice to various departments for generating data for API DMF submission and thereby helping companies in creating revenue. Having quality module 3 in line with current regulatory standards forces formulators to purchase API from that company. Out of 3 CTD modules of dossier, quality module 3 is a key module which covers scientific data on drug substance. The discussion enclosed here will help students understand every section of the quality module thoroughly. It also covers examples, templates etc.

Category: Crash Courses
Duration : Training duration: 5 hours, course would be accessible for 1 month from the date of admission

Learning objectives

Knowledge of the following topics:

3.2.S  Drug Substance: 3.2.S.1   General Information, 3.2.S.2   Manufacture, 3.2.S.3   Characterisation, 3.2.S.4   Control of Drug Substance, 3.2.S.5   Reference Standards or Materials, 3.2.S.6   Container Closure System, 3.2.S.7   Stability

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: ICH CTD introduction & Module 3 Drug substance 5 hours

    • ICH M4Q CTD format introduction 45 minutes
    • Module 3 Drug substance sections S.1, S.2, APISM, ICHQ11 reference 150 minutes
    • Module 3 Drug substance sections S.3, S.4, S.5 80 minutes
    • Module 3 Drug substance sections S.6, S.7 36 minutes

Fees : 5074

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    Course Include :
  • Video
  • Audio
  • PPT
  • PDF
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