Institute of Good Manufacturing Practices India
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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)
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Post Graduate Diploma in  Post graduate diploma in regulatory affairs (medical device as major)

Before a medical device can enter any market, it needs to fulfill all the applicable regulatory requirements and gain approval from the concerned regulatory bodies. Regulatory and demographic environment is a part of challenge to medical device industry. The real struggle is to define the strategy, development of appropriate business plan and efficient execution of the same. For that technical expertise is required. All employees should be aware of the expectations and procedures within the company. Assessment of employees is done on the basis of their knowledge and skill.

IGMPI offers an Executive Diploma Course in Medical Device Regulatory Affairs. The curriculum is designed and developed by experts from the medical device industry and is focused on both theoretical and practical aspects. The course is meant for Graduates and Post Graduates, employed plus yet to be employed candidates willing to enter this exciting field of liaison between the technical aspects of a medical device as well as the legal role of submissions and approvals.

Programmme Structure

Module 1 : Introduction to Global Regulatory Authorities for pharma and healthcare industries

Module 2 : Medical Devices, In –vitro devices, Biologics & Combination Products: Introductory Module

Module 3 : FDA Regulations and Guidelines on Medical Devices

Module 4 : European Union Regulatory Guidelines on Medical Devices

Module 5: Medical Device Regulations from Indian perspective

Module 6: Management of the risks associated with Medical devices

Module 7: Biocompatibility Studies and Medical Devices

Module 8: Clinical Trials: Medical Devices

Module 9: Overview of In – Vitro Device Regulation

Module 10: Overview of Combination Products Regulation

Module 11: Dossier preparation in CTD format, eCTD submissions

Eligibility

All those working in the Pharmaceutical Industry or any sector of healthcare or any other industry type (India or abroad) can apply for this short term programme. Life Science Graduate /B.Pharm/M.Pharm/M.Sc/Phd/Diploma holder in science disciplines/ or passed out of clinical research degree or diploma courses are also eligible for the course. Working Professional of any of the following industry types Food Manufacturing, Food Industry and Additive Processing, Drugs Manufacturing, Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing , Cosmetic Manufacturing , Biotechnology or any related industry are highly encourage to apply for the programme.

Programme Duration

Minimum time in which a student can complete this diploma course is 6 months while a maximum of 12 months is allowed to complete the course.

Registration

The registration dates for this bi-annual program run by the institute are updated timely on the webpage. The Training sessions and webinars are strictly scheduled depending on the availability of speakers. 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.

Programme Fee

A one-time fees (lump sum paid at beginning of the course) of Rs 20,000 /- (700 USD for oversees students) is mandatory. This covers for the course registration fees, tuition fees, course material fees etc. Apart from this, an examination fee of Rs 400/- (USD 15) per module needs to be paid later as per the examination notification of the Institute.

Examination & Certification

All the participants are obliged to timely submit completed assessment assignments (during the course, usually after every module) and appear for an online exam at the end of the course. After successful completion, the participants will be awarded Executive Diploma in Regulatory Affairs (Medical Device as Major) by IGMPI. This programme is approved by Quality Council of India (QCI), Government of India.

For all the above mentioned modules elaborate course material, self-assessment assignments and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

IGMPI offers placement assistance to its students. The Institute has partnered with many organizations for providing 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 employability of our participants. 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, Medical devices 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, Biocon , Hindustan Syringes & Medical Devices, Wipro GE Healthcare, Medtronic, Bausch & Lomb, Baxter, Sushrut Surgicals, Wipro Technologies, HCL Technologies etc.

Future and career prospects of the Training Course in Regulatory Affairs (Medical Device as Major)

Medical Devices Industry is highly alluring sector now a days. Hence, there is fierce competition in this sector. Proper training and knowledge in this field is required so as to reach the pinnacle of success in this particular sector.

Professional and industry oriented training courses such as Medical Device Management by IGMPI, open doors for entry into the industry. Executive Diploma in Regulatory Affairs (Medical Device as Major) is a fast track course which endows theoretical as well as practical knowledge to the candidate required to sustain successfully in industry. After the completion of this course the candidate gets selected in industry /sector of his/her interest. This course is also beneficial for working professionals to gain hike in their sector by getting updated knowledge of the field.

How to apply

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

[email protected]/+91 8130924488, +91 8587838177, 0120-4375280

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