Post Graduate Diploma/Executive Diploma in Pharmaceutical Good Laboratory Practice (PGDGLP/EDGLP)

The international standard of GLP or Good Laboratory Practice is a quality system used in research labs. As part of their responsibility, scientists have conventionally adopted good laboratory practices directed at ensuring the quality of their data. Nevertheless, until recently these practices were not consistently adopted or enforced. But, now national and international agencies have developed guidelines aimed at various industries (food, agriculture, pharmaceutical, clinical, biotech, cosmetics, environmental, etc.) which fall in the general category of Good Laboratory Practices (GLP).

Since the issue of GLP is so important to modern laboratory operations, this programme will incorporate many of the principles that are part of GLP in contemporary commercial laboratories. It will be useful for next generation individuals seeking careers in the industry who need practical skills and expertise for the pharmaceutical, biotechnology and healthcare workforce.This curriculum is specifically designed to help participants by:

• Improving knowledge and understanding of the GLP principles and its regulatory basis ;
• Overview of current GLP status as well as achieving compliance with GLP regulations ;
• Understanding the requirements of a laboratory facility;
• Comprehensive information about documentations, such as Standard Operating Procedures, protocols, study plans, data quality and integrity, auditing, etc.;

On successful completion of this programme, participants are expected to have better understanding of the requirements of GLP for the efficient working of a testing laboratory by applying the knowledge into practice. The programme provides an overview of ISO / IEC 17025: 2005 as well as the common requirements of GLP Compliance (OECD & FDA) as applicable to various testing Laboratories and research organizations. This will also include recent developments related to computer validation.

- Covers key areas through programmes that integrate theory and practice

Programme Modules

Module 1 : Introduction, fundamentals and principles of GLP

Module 2 : Documentation, records and preparation of SOPs

Module 3 : GLP compliance & preparation for certification; ISO / IEC 17025: 2017 & Laboratory accreditation

Module 4 : Internal Quality Audits for various Quality Management Sytems (QMS)

Module 5 : Use of Computers in the laboratory

Module 6 : General Good Testing Conduct

Module 7 : International GLP of the OECD, FDA etc

Module 8 : Management, Personnel, Buildings & Equipment

Module 9 : Method Validation and Quality Assurance

Module 10 : Inspection of a testing facility

Module 11 : Demonstration of Instrument Handling used in Pharmaceutical Laboratory

Module 12 : Case studies

Eligibility

Graduate in any discipline is eligible for our Post Graduate Diploma and Certificate Programmes. For Executive Diploma programmes and Professional Certifications, you need to have at least 1 year of work experience.

Programme Duration

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

Programme Mode

Registrations are currently open for regular and online both modes.

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 & 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 Good Laboratory Practice, 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 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 Dr. Reddy’s Laboratories, IPCA Laboratories, Zydus Cadila Healthcare Ltd., Intas Pharmaceutical Ltd., Novartis Life Sciences Ltd., Lupin Ltd., Unison Pharmaceuticals Pvt. Ltd., IQVIA, Labcorp, Baxter India, Galentic Pharma (India) Pvt. Ltd., Syngene International Limited, Merck Ltd., Indoco Remedies Ltd., 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 of Pharmaceutical Good Laboratory Practice

The participants of this programme have prospective career opportunities in clinical investigation, laboratory management, research, teaching, production, record keeping, technical writing and related activities. They can also work as medical laboratory scientists in diagnostic laboratories, pathology departments in government and private hospitals, pharmaceutical companies and research institutes. Those who are already working in these areas will be benefitted by the programme in terms of career enhancement and growth within the organisation or at the time of switching their organisations

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Programme Fee Details

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in