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

IGMPI

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.

Programme Modules

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

  • Basics of Quality
  • Quality Management System
  • Need of Quality in Clinical Research
  • Introduction to QA and QC
  • Module 2: Qualification and Validation

  • Introduction to Validation
  • Validation Master Plan
  • Qualification: DQ, IQ, OQ, PQ, Calibration and Maintenance
  • Validation: Process Validation, Analytical Method Validation, Water System Validation, HVAC, Cleaning Validation, Sterilisation Validation, Computer System Validation
  • Module 3: Quality Assurance and Quality Control- Possible Problems and Fixes

  • Deviations
  • Out of Specification (OOS) and Out of Control (OOT)
  • Change Control
  • Compliance
  • CAPA
  • Module 4: Types of Quality Testing

  • Analytical and Bioanalytical Techniques
  • Clinical Sample Handling
  • Clinical Sample Testing
  • Module 5:Quality Testing Tools and Techniques

  • Quality Testing Tools
  • Quality Assurance Tools
  • Statistical Process Control
  • Quality Management Tools
  • Module 6: Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000

  • Global Regulatory Authorities; USFDA, EMA, UKMHRA, TGA, CDSCO
  • ICH, WHO, PIC/S
  • International Council on Harmonisation (ICH)
  • ICH Guidance on: Quality, Safety, Efficacy and Multidisciplinary
  • International Organization for Standardization (ISO)
  • ISO 9000, 9001:2015 series
  • Module 7: Total Quality Management and GMP, Quality Risk Management, Assessing Quality Concerns at Different Work Units or Areas

  • ICH Pharmaceutical Quality System
  • Quality Culture
  • Quality Policy
  • Quality Commitment
  • Continuous Improvement: Kaizen, LEAN Six Sigma
  • GMP Regulations: USFDA, EU, TGA, ICH, WHO
  • ICH Quality Risk Management
  • Guidelines on Quality Risk Management: USFDA, WHO, EU
  • Quality Defects
  • Defect Identification Tools
  • Root Cause Investigation
  • Deviation, Change Control, CAPA. Complaint and Recall Handling
  • Module 8: Documentation, Good Documentation Practices, SOPs, Protocols, etc.

  • Principles of GDP
  • Types of SOPs
  • Designing Clinical Trial Protocol
  • Protocol deviations and Violations
  • Data Integrity
  • Analytical Test Protocol, Work Instructions, Checklists, Log books
  • Module 9: Introduction to Clinical Research Industry and Basics of Clinical Trials

  • Clinical Research Industry
  • Difference between Clinical Research and Clinical Trials
  • Clinical Research terminologies
  • General Medical Terminologies
  • Module 10: Pharmacology-Concepts and Application in clinical trials

  • Basics of Pharmacology
  • Pharmacodynamics
  • Pharmacokinetics
  • Routes of Administration
  • Dosage forms
  • Module 11: Drug Development Process

  • Drug discovery
  • Target Identification
  • Lead Identification
  • Lead Optimization
  • Preclinical studies
  • Module 12: Biostatistics- Concepts and Application in Drug Development and Clinical Research

  • Defining the Research Problem
  • Sampling Design
  • Hypothesis testing
  • Parametric and Non parametric test
  • Module 13: Ethics and Ethical Guidelines for Clinical Trials, and Drug Development Industry

  • History of ICH
  • ICH Guidelines
  • ICH GCP- E6 R2
  • ICMR Ethical Guidelines
  • Ethics on use of Placebo in Clinical Trials
  • Module 14: Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies

  • CDSCO, India
  • ICMR, India
  • USFDA, USA
  • EMEA, Europe
  • MHRA, UK
  • TGA, Australia
  • Module 15: Outsourcing Clinical Trials, functioning of Clinical Research Organisations

  • Stakeholders in Clinical Trial
  • Introduction to CROs
  • Roles and Responsibilities of CRO
  • QA and QC of outsourced vendors in Clinical Trials
  • Module 16: Introduction to Quality Assurance and Quality Control in Clinical Trials

  • Introduction to Quality Management System
  • Quality Assurance
  • Quality Control
  • Audits and Inspection
  • Module 17: Quality Management System in Clinical Trails

  • Difference between QA and QC
  • Difference between Audits and Inspection
  • Types of Monitoring
  • Responsibilities of QA QC Auditor
  • Module 18: Various types of Audits in Clinical Trails

  • Routine Audits
  • For Cause Audits
  • Regulatory Audits
  • Sponsor Audits
  • Module 19: Clinical Trials Audit observations and study of critical observations

  • Review of Investigator site documents
  • Ethics committee submissions and Notifications
  • Site Facilities Audits
  • Consequences of Non compliance
  • 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

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


    View 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

    Pharmaceuticals | Food | Clinical Research | Healthcare | Medical Coding | Medical Device | Nanotechnology | IPR

    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.


    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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    By Shri Vinod Arora, Principal Advisor, IGMPI


    Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like

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