. Executive diploma in quality assurance and quality control (clinical research as major) Delhi NCR, Vadodara
Institute of Good Manufacturing Practices India

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Executive Diploma in   quality assurance and quality control (clinical research as major)(QCI, Government of India Approved & Certified)

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 course for those already in the industry and an insight or practical guide for those planning to enter into this sector. You can complete this course 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.

Module 1 : Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare 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: Documentation, Good Documentation Practices, SOPs, Protocols, etc.

Module 17: Introduction to Quality Assurance and Quality Control in Clinical Trials

Module 18: Quality Management System in Clinical Trails

Module 19: Various types of Audits in Clinical Trails

Module 20: Clinical Trials Audit observations and study of critical observations

Module 21: Industry Based Case Studies

Eligibility

All those who have completed their Graduation or Post Graduationin Life Sciences are eligible to enroll for the course. As this course is truly professional and industry oriented, employed individuals working in any sector (production, processing, quality, trial, R&D etc.) in the 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 also seek benefits of the course.

Programme Duration

Minimum duration to complete this program is 6 Months while a maximum of one year is allowed to complete the course.

Registration

The registration dates for this bi-annual executive program run by the institute are updated timely on the webpage. The Training sessions and webinars are strictly scheduled depending on the availability of speakers. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.

Programme Fee

A one-time fees (lump sum paid at beginning of the course) of Rs 22,000 /- (700 USD for oversees students) is mandatory. This covers for the course registration fees, tuition fees, course material fees etc. Apart from this, an examination fee of Rs 400/- (USD 15) per module needs to be paid later as per the examination notification of the Institute.

Examination & Certification

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). For all the above mentioned modules elaborate course material, self-assessment assignments and project work details would be provided by the Institute from time to time. 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, healthcare and Cosmetic industries like Lakme, VLCC, Natures, Modicare, Lotus Herbals, Dr. Reddy’s Laboratories, AurobindoPharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Bliss GVS Pharma, Al Rawabi, SeQuent, PepsiCo India, Mankind, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy, Biocon etc.

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. 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 course 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 course 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 course 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.

How to apply

For further enquiries or Prospectus, write to or call us on:
info@igmpiindia.org/+91 8587838177, +91 8130924488, 0120-2427175, 0120-4375280
(10 AM IST to 5.30 PM IST)

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