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Executive Diploma in quality assurance and quality control (clinical research as major)


This short term programme has been designed mainly to provide brief of Quality Assurance and Quality Control (Clinical Research as Major). The programme provides collecting, linking, and manipulating different types of biological information to discover new biological insight. Thus it works as re-fresher programme for those already in the industry and an insight or practical guide for those planning to enter into this sector. You can complete this programme from your own city.

All the above as well as practical knowledge about the subject has been included as case studies, practice modules, e-sessions and lectures, e-classrooms and discussions etc. The sole aim remains to make ready candidates with ample and appropriate knowledge about varied quality issues, concerns, industry needs, techniques, legislative norms and precise knowledge for identifying and overcoming quality related problems arising at work place. With this knowledge the participant can confidently aim to apply for and be a part of healthcare production units, quality check divisions of manufacturing plants and even quality auditing boards and regulatory authorities.

Programme Modules :

Module 1 : Quality, Quality Assurance and Quality Control in pharmaceutical industries

Module 2 : Qualification and Validation

Module 3 : Quality Assurance and Quality Control- Possible Problems and Fixes

Module 4 : Types of Quality Testing (models, types, procedures etc.)

Module 5 :Quality Testing Tools and Techniques

Module 6 : Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000

Module 7 : Total Quality Management and GMP, Quality Risk Management, Assessing Quality Concerns at Different Work Units or Areas

Module 8 : Documentation, Good Documentation Practices, SOPs, Protocols, etc.

Module 9 : Introduction to Clinical Research Industry and Basics of Clinical Trials.

Module 10 : Pharmacology-Concepts and Application in clinical trials

Module 11 : Drug Development Process

Module 12 : Biostatistics- Concepts and Application in Drug Development and Clinical Research

Module 13 : Ethics and Ethical Guidelines for Clinical Trials, and Drug Development Industry

Module 14 : Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies

Module 15 : Outsourcing Clinical Trials, functioning of Clinical Research Organisations

Module 16 : Introduction to Quality Assurance and Quality Control in Clinical Trials

Module 17 : Quality Management System in Clinical Trials

Module 18 : Various types of Audits in Clinical Trials

Module 19 : Clinical Trials Audit observations and study of critical observations

Module 20 : Industry Based 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.

Programme Duration

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

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 & 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 Executive Diploma in Quality Assurance and Quality Control (Clinical Research as Major) by Faculty of Clinical Research, 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 IQVIA, Parexel, Syneos Health, Fisher Clinical Services, Dr. Reddy’s Laboratories, Divi’s Laboratories, GVK Biosciences, Avra Labs, SRL Ranbaxy, Torrent Pharmaceutical Ltd., Novartis Life Sciences, Jubilant Lifesciences Ltd., Aurobindo Pharmaceuticals Ltd., Venus 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 Quality Assurance and Quality Control (Clinical Research as Major)

IGMPI offers professional and industry oriented training in Quality Assurance and Quality Control (Clinical Research as Major) thus opening doors for entry into the industry. Executive diploma in PV adds advantage for those already in the industry as a tag of professional training and those new to the industry feel comfortable with backing of apt and up-to-date information and training required to have sustained growth in the industry.

It is a broad spectrum programme which offers to entail the candidate with knowledge and practically important information about the industry type, working modalities, methodology of trials, techniques of quality control, drug development, post marketing safety checks and all other aspects related to the clinical research industry. With the completion of this programme the candidate gets to select from varied work areas of the industry/sector of his/her interest. Knowing all faces of the industry, candidate can target to specifically enter the drug development, CTs, Data Management, and Regulatory Affairs, Quality Assurance or Post marketing Surveillance teams of various Pharmaceutical companies. Same is true for the professionals who are already a part of the industry but are keen on making lateral movement in their company by shifting to other department.


Download Prospectus

Programme Fee Details

How to apply

For further enquiries, write to or call us on::
info@igmpi.ac.in / 18001031071 (Toll Free), Phone: +91 11 26512850

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Clinical Research Newsletter


FCR Placement Blog


All existing and old students and training participants are requested to write to our Corporate Resources division on info@igmpi.ac.in along with your updated resume mentioning their Enrollment No. for registration with our Placement Cell asap, if not registered yet.


Moderated by Shri Vinod Arora, Principal Advisor, IGMPI


Moderated by Shri Vinod Arora, Principal Advisor, IGMPI

Moderated by Shri Vinod Arora, Principal Advisor, IGMPI


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