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
Module 4 :Industry specific case studies
Any Life Science graduate/ B.Pharm/M pharm/MSc/ 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.
The candidate is expected to complete the course in 3 months.
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.
The mandatory course fee (one-time payment) for the distance cum e learning mode is Rs. 14,500/- (500 USD for overseas students). This covers for the course registration fees, tuition fees, course material fees etc. Apart from this, an examination fee of Rs 450/-(USD 20) per module needs to be paid later as per the examination notification of the Institute.
IGMPI follows a credit system based on all all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.
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.
The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.
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.
The DMF summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development. Attendees will learn the differences between the five types of DMFs and the detailed information required within each type of DMF. Using a series of case studies, the course will highlight real word examples and actual experiences with FDA submissions related to DMF components. Upon completion of the course, attendees will be able to begin developing or to improve upon their DMF file documentation. Professionals working in manufacturing, Regulatory affairs, research and development, QA and QC, validation and development and preparation of submission material will be highly benefited by this course.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like