Post Graduate Diploma in Pharmaceutical Technology Transfer (12 months)

Executive Diploma in Pharmaceutical Technology Transfer (6 months)

www.igmpi.ac.in


About IGMPI


The Institute of Good Manufacturing Practices India, registered under SR Act XXI of 1860, Government of India, recognised by Ministry of Commerce & Industry, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI) presents a unique, friendly and interactive platform to get rid of all your GMP compliance related issues. GMP- an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing and sustainability services - in itself is the most dynamic part which witnesses frequent changes in terms of new rules being added and old ones being renewed. Thus, keeping oneself updated with current GMPs is essential to remain aligned with evolving industry requirement and standards.

Our team comprises knowledgeable professionals from diverse sectors such as Pharma, Healthcare, Food & Nutraceutical industries, pooling together their expertise, know-how, and practical experiences to create this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better education and training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food & Nutrition and Healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which includes GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite training programmes along with the knowledge of worldwide affairs of the industry. In short, a round-the-clock service is provided for any information in these areas required by anybody from around the country and abroad. Based on high standards 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. IGMPI is duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018.

Accreditation and Awards

IGMPI is recognized by the Ministry of Commerce & Industry, Government of India and duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018 (License number: ERO/EOMSM/L-8000027) for offering education and training programmes, services and processes in the areas of Pharmaceutical, Food, Nutrition, Healthcare, Environment Health & Safety (EHS), Environmental Social & Governance (ESG) and Marketing Communications.

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.

IGMPI has been conferred with the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023". 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

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.

Quality Council of India (QCI)

Quality Council of India is set up by the Government of India to establish and operate national accreditation structure and promote quality through National Quality Campaign. QCI is registered as a non-profit society with its own Memorandum of Association. QCI is governed by a Council of 38 members and Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government. The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI.

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 CarelSQua

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 Pharmaceutical Technology Transfer


Technology transfer (TT) includes knowledge transfer, science and risk-based principles including ICH Q8, Q9, Q10, Q11 and efficient processes to meet evolving business needs. Appropriate technology transfer is both integral and critical to drug discovery and development for new medicinal products. It is also important to upgrade drug quality designed during research and development and to finalize product during manufacturing as well as to assure stable quality. This programme will provide understanding of the technology transfer of analytical methods, quality control standards, packaging components, operations and various pharmaceutical dosage forms from R&D to manufacturing. It is designed to provide an understanding of the issues affecting the transfer within and outside a company.

Programme Modules

Module 1: Introduction to Technology Transfer

Module 2: Technology Transfer in Contract Research and Manufacturing Services (CRAMS)

Module 3: Technology Identification & Assessment

Module 4: Regulatory aspects (India & International): FDA regulations and ICH guidelines

Module 5: Intellectual Property Rights

Module 6: Customer Relations and Vendor management

Module 7: Technology valuation, deal making & new product implementation

Module 8: Pharmaceutical Process Engineering

Module 9: R & D trials and Spin-out Development

Module 10: Pilot plant-Scale up & Hazop studies

Module 11: Validation, Commercial plant trials & various functions of departments

Module 12: Materials Management

Module 13: Technology Transfer Case Studies

Eligibility

Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Working professional of any of the following industry types, Drug 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.

As this programme is truly professional, Managerial and industry oriented, employed individuals working in any sector (production, processing, quality, control, Process engineering, technology transfer, Pilot trial, R&D etc.) in any healthcare industry (Food manufacturing, Food Ingredient and Additive processing, Drugs manufacturing , Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology) can seek benefits of 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 obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will receive a certificate of Post Graduate Diploma/Executive Diploma in Pharmaceutical Technology Transfer, 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 healthcare like, Aphena Pharma Solutions, Eli Lilly and Co., Bayer AG, AbbVie, Pfizer, GlaxoSmithKline, Johnson & Johnson Piramal Pharma Solutions, Mankind Pharma Ltd., Cipla, Coral Drugs Pvt. Ltd., Zydus Life sciences, Gland Pharma, Novo Nordisk, Jubilant Life sciences Ltd., Uflex Ltd., Anuroop Packaging Ltd., IPCA, Zydus, Unichem, Sun Pharmaceuticals, Hetero, Torrent Pharmaceutical, Cipla, Lupin, Johnson & Johnson, Pfizer, Roche, Intas, Asrezenenca, Gland, Glenmark, Macleods, Jubilant Lifesciences, Novartis, Merck, Piramal, Dr. Reddy’s Laboratories, Hamdard, Lotus, Lakme, Khadi, Himalayan, 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

Pharmaceutical Technology transfer provides a strong focus on problem solving, as well as technical and practical application of knowledge to particular fact scenarios through a number of advice drafting exercises. The Technology Transfer professionals will execute the process development experiments and process optimization of API & formulations, Scale-up of API & formulations from lab scale to pilot/commercial scale, execution of submission batches and validation, Preparation & review of batch documents & protocols. Technology Transfer is important in extending benefits of R&D to the society at a large, especially in developing countries. Technology Transfer is important for commercialization especially, in the case of developing and underdeveloped countries.


Advisory Board and team


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


Institute of Good Manufacturing Practices India

A-14/B, A Block, Qutab Institutional Area, Near Old JNU Campus New Delhi – 110067, India.
18001031071 (Toll Free), Phone: +91 11 26512850