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, 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 : 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
All those who have completed their Graduation or Post Graduation in 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.
Minimum duration to complete this program is 1 year and maximum is 2 years.
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.
IGMPI follows a credit system based on all 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 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.
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 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.
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.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like