Institute of Good Manufacturing Practices India
Global accredited training & certification provider
Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India
Approved Training Partner of Food Safety and Standards Authority of India (FSSAI)
An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India
Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
Affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council set up by National Skill Development Corporation (NSDC)
Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD & ASSOCHAM Services Excellence Award 2017

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CERTIFICATE PROGRAMME IN  PREPARATION AND SUBMISSION OF DRUG MASTER FILE (DMF)

This course is designed for professionals to provide an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. This course will explain step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. This will be of great benefit to regulatory compliance professionals working on DMF, NDA, IND or ANDAs, Regulatory affairs professionals, attorneys, project managers, and management professionals in small and midsize manufacture operations.

Module 1 :Drug development process and regulatory filings

Module 2 :Introduction to Drug Master Files and its Types

Module 3 :Preparation and Submission of Drug Master File

Eligibility

Any Life Science graduate/ B.Pharm/M pharm/MSc/Phd in science disciplines/ any diploma holder or passed outs of Clinical Research degree or diploma courses are eligible for these course. Working professionals of any of the following industry types Drugs manufacturing , Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.

Programme Duration

The candidate is expected to complete the course in a minimum of 1 and maximum of 3 months.

Registration

The registration dates for this programme run by the institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self regulated and self-paced performance to the participants.

Programmes Fees

A one-time fees (lump sum paid at beginning of the course) of Rs 7,500/- (300 USD for oversees students) is mandatory. This covers for the course registration fees, tuition fees, course material examination fee etc.

Examination & Certification

All the participants are expected to appear for online exam and are also obliged to submit assignments after each module. After successful completion the participants will be awarded Certificate in Preparation and submission of drug master file (DMF). For all the above mentioned modules elaborate course material, assignment and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well.

Corporate Relations

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.

For further enquiries or Prospectus, write to or call us on:

[email protected]/+91 8130924488

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