Post Graduate Diploma in Medical Device Management (12 months)

Executive Diploma in Medical Device Management (6 months)

www.igmpi.ac.in


About IGMPI


Institute of Good Manufacturing Practices India, registered as a non-profit society (under The Societies Registration Act,1860) with Government of India recognised by Ministry of Commerce & Industry, Government of India, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI) presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses frequent changes in terms of newer rules being added and older ones being renewed. Keeping self updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices.

Our group of learned professionals from above mentioned sectors of the Pharma, Healthcare and Food industries have put together their knowledge; know about and practical experiences in form of this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. The importance of quality healthcare and foods is known to our founders and thus numerous efforts are being made to offer friendly but effective and easy regular and online/online sources of GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite training programmes along with knowledge of worldwide affairs of the industry; in short a round-the-clock help for any information in these areas needed by anybody from around the world. Based on high standard of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC etc areas have been approved by Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India.

The IGMPI's team of technology experts and other Industry advisors together pursue to make cGMP knowledge, training in the area of Pharma and Food manufacturing easily accessible, through this platform.

Accreditation and Awards

IGMPI is recognized by the Ministry of Commerce & Industry Government of India. Duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018 (License number: CRO/QM/L-8004228) for offering education and training programmes in the areas of Pharmaceutical, Food, Nutrition and Healthcare.

Ministry of Commerce & Industry
Bureau of Indian Standards

Institute of Good Manufacturing Practices India (IGMPI) is registered as a non-profit society with its own Memorandum of Association and bye-laws under The Societies Registration Act, 1860, Government of India. IGMPI is an accredited Vocational Institution of Ministry of Education, Government of India.

The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:

  1. Programme Content
  2. Programme Design
  3. Programme Material
  4. Instructors
  5. Class size & Attendance
  6. Facilities
  7. Evaluation of Students
  8. Written Examination
  9. Certificate

IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006. QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.

IGMPI's Membership with IPA

IGMPI is a Lifetime Institutional member of Indian Pharmaceutical Association (IPA).

IPA

IGMPI's Membership with AFSTI

IGMPI is an Institutional member of The Association of Food Scientists and Technologists (India), (AFSTI).

AFSTI

Bureau of Indian Standards (BIS)

Bureau of Indian Standards (BIS) came into existence through an act of Parliament in 1987. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. The Bureau is a Body consisting of 25 members representing both Central and State governments, Members of Parliament, industry, scientific and research institutions, consumer organizations and professional bodies; with Union Minister of Consumer Affairs, Food and Public Distribution as its President and with Minister of State for Consumer Affairs, Food and Public Distribution as its Vice-President.

International Recognition

For providing its education and training services to overseas students, IGMPI is registered with the Directorate General of Foreign Trade, Government of India and our Export Import Code is AADCI7680Q.

IGMPI is an Institutional Member of the International Society for Quality in Health Care lSQua

Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.


Post Graduate Diploma/Executive Diploma in Medical Device Management


A medical device includes some of the genuine miracles of modern medicine and offers great challenges. This Industry is knowledge based economy and provides sustainable employment. This can generate exports into rapidly expanding global market.

The Post Graduate Diploma/Executive Diploma Programme offers an opportunity to study in a stimulating environment which includes experience and insights of industry professionals. This programme is offered through online learning modes with the following features:

  • Economic
  • Expedient Access
  • Self paced learning module
  • Flexibility
  • Different learning styles
  • Successful completion

Professionally trained personnel are required to sustain in such challenging environment. IGMPI provides theoretical as well as practical knowledge which provides assurance of sustainability and success in this industry. The programme is meant for all those keen on being a part of Medical Device industry and even working professionals can apply for the programme and affirm a strong position in the industry.

The programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Medical Devices industry as their career choice.

Programme Modules

Module 1: Medical Devices, In –vitro devices, Biologics & Combination Products: Introductory Module

Module 2: Current Good Manufacturing Practices (International Perspective)

Module 3: Current Good Manufacturing Practices (Indian Perspective)

Module 4: Qualification and Validation

Module 5: Types of Quality Testing (models, types, procedures etc.) in Medical Device

Module 6: Quality Management System (International Perspective)

Module 7: Medical Device Regulatory Affairs (International perspective, USA) Part 1

Module 8: Medical Device Regulatory Affairs (International perspective, USA) Part 2

Module 9: Medical Device Regulatory Affairs (International perspective, EU) Part 1

Module 10: Medical Device Regulatory Affairs (International perspective, EU) Part 2

Module 11: Medical Device Regulatory Affairs (Indian perspective)

Module 12: Introduction to Risk Management to Medical Devices

Module 13: Biocompatibility Studies

Module 14: Clinical Trials: Medical Devices

Module 15: Materiovigilance across the Globe

Module 16: Overview of In – Vitro Device Regulation

Module 17: Overview of Combination Products Regulation

Module 18: Artificial Intelligence in Medical Devices

Module 19: Medical Devices and allied fields: Emerging Area

Eligibility

BTech/Bsc in Biotechnology/ Microbiology/ Botany/ Zoology/ B.Pharm/M Pharm/MSc / MBBS/ BDS/ BHS/ BUMS/ BAMS/ Graduation in Life science disciplines are eligible for the programme.

Programme Duration

The duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Executive Diploma).

Registration

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

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • Assignments for all the programme modules for continuous evaluation and guidance.
  • Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
  • Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination
  • All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • All learning and training delivery initiatives shall be conducted in English.

Examination and Certification

IGMPI follows a credit system based on 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 an online exam and are also obliged to submit assignments after each module. After successful completion, the participants will be awarded Post Graduate Diploma/Executive Diploma in Medical Device Management by Faculty of Medical Device Management, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

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 like Abbott Laboratories, Medtronic PLC, Baxter International, Danaher Corporation, General Electric, 3M Company, Siemens Healthineers, Stryker Corporation, ResMed Inc., Cardinal Health Inc., Fonar Corporation, Invacare Corporation, Luminex Corp., Mesa Laboratories Inc., Nevro Corp., Smith & Nephew PLC, 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 industries on regular basis.

Future career prospects

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 particular sector.

Professional and industry oriented training programmes such as Medical Device Management by IGMPI, open doors for entry into the industry. Post Graduate Diploma/Executive Diploma in Medical Device Management is a broad spectrum programme which endows theoretical as well as practical knowledge to the candidate required to sustain successfully in industry. After the completion of this programme the candidate gets selected in Associate medical manager, clinical medical manager, clinical operations manager, therapy development specialist, territory manager sales, product manager & industry/sector of his/her interest. This programme is also beneficial for working professionals to gain hike in their sector by getting updated knowledge of the field.


Advisory Board and team


Our Advisory Board Members : https://igmpi.ac.in/advisoryboard.html


Qutab Institutional Area (Near Old JNU), New Delhi–110067 | Sector 63, Noida, Delhi NCR–201301, India.
18001031071 (Toll Free), Phone: +91 11 26512850