Post Graduate Diploma/Professional Diploma in Quality Assurance and Quality Control (Clinical Research as Major)
Over the recent years, the concept of Good Clinical Practice (GCP) has rapidly evolved over the world, with guidelines and regulations now existing not only in the U.S.A. but also in Europe, Scandinavia, Japan, and Australia. The systematic measures laid down in GCP are to ensure that clinical studies are conducted in conformity with strict ethical rules, are performed
According to high-quality standards, and result in authentic, verifiable scientific data. Quality control (QC) in clinical trials means the procedures which insure protection of human subjects from research risk, reliability of the data, and thereby assures internal consistency. The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are generated, documented (recorded) and reported in compliance with the protocol, GCP, and the applicable regulatory requirements.QA departments often assist in laying down investigator sites selection standards, identifying service providers to be audited, for instance laboratories, drug packaging and supply vendors.
All the above as well as practical knowledge about the subject has been included as case studies, practice modules, e-sessions and lectures, online-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.
Programmme 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
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 Trails
Module 18: Various types of Audits in Clinical Trails
Module 19: Clinical Trials Audit observations and study of critical observations
Module 20: Industry Based Case Studies
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 (Professional 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 & 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.This programme is approved by Quality Council of India (QCI), Government of India.
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 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 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 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
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. The functions of the quality assurance department in the case of a particular clinical trial are very diverse.QA departments identify what internal procedures of the research will be audited from initial study design, site and data supervision, statistical evaluation, and the final CSR.This programme 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 sustain and grow 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.
For further enquiries, write to or call us on:info@igmpi.ac.in / 18001031071 (Toll Free), Phone: +91 11 26512850
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Placement Testimonials
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.
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