Post graduate Diploma/Executive Diploma in  Pharmaceutical Quality Assurance and Quality Control (PGDQAQC/EDQAQC)

IGMPI

The programme targets graduate, post graduate and already employed candidates with keen interest in the Quality Assurance and Quality Control divisions of an industry. The Post graduate Diploma/Executive Diploma/Industry Certification programmes is aimed to make the participant learn the:

- Need of QA & QC

- Where and when to apply
- Current norms and regulations (for both compliance and non-compliance)
- Testing tools and techniques
- Overcoming QA problems and fixing methods

All the above as well as practical knowledge about the subject has been included as case studies, practice modules, online 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.

Programme Modules

Module 1: Quality Assurance and Quality Control in pharmaceutical industry

  • Basics of Quality
  • GMP Regulations: USFDA, EU, TGA, ICH, WHO
  • Need of Quality
  • 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: Quality Statistical Tools and Techniques

  • Quality Testing Tools
  • Quality Assurance Tools
  • Statistical Process Control
  • Quality Management Tools
  • Module 5: Quality Testing and its types

  • Analytical Techniques
  • API testing
  • Raw material testing; Excipients, intermediates and container closure
  • Finished Product Testing
  • Stability Testing
  • Microbiological testing
  • Module 6: Drug Stability Study

  • ICH Stability Testing
  • Stability Testing of new Drug Substances and Products
  • ICH Impurities Testing
  • Module 7: Regulatory Authorities and Quality Certification

  • Global Regulatory Authorities; USFDA, EMA, UKMHRA, TGA, CDSCO
  • ICH, WHO, PIC/S
  • Module 8: ICH Guidelines and ISO

  • International Council on Harmonisation (ICH)
  • ICH Guidance on: Quality, Safety, Efficacy and Multidisciplinary
  • International Organization for Standardization (ISO)
  • ISO 9000, 9001:2015 series
  • Module 9: Quality Risk Management

  • ICH Quality Risk Management
  • Guidelines on Quality Risk Management: USFDA, WHO, EU
  • Module 10: Total Quality Management

  • ICH Pharmaceutical Quality System
  • Quality Culture
  • Quality Policy
  • Quality Commitment
  • Continuous Improvement: Kaizen, LEAN Six Sigma
  • Module 11: Addressing Internal and External Quality Issues

  • Quality Defects
  • Defect Identification Tools
  • Root Cause Investigation
  • Deviation, Change Control, CAPA. Complaint and Recall Handling
  • Module 12: Inspections and Audits Types, Non Compliance handling

  • Types of Audits and Inspections
  • Regulatory Audits (FDA, MHRA, PMDA, TGA, DCGI)
  • Audit Observations, Response letters, Warning letters, Revocation of GMP license
  • Breach Reports
  • Module 13: Good Documentation Practices, SOPs, Protocols, etc

  • Good Documentation Practices (GDP)
  • Data Integrity
  • SOP, Analytical Test Protocol, Work Instruction, Checklists, Log books
  • Module 14: Online Laboratory demonstration of analytical techniques

  • Introduction to GCC
  • Drug Approval and Review Process in GCC
  • GMP Requirements: WHO, license, forms, procedures, inspection
  • Dossier compilation and submission requirements
  • Import and Export requirements
  • Module 15: Software Based Analysis

  • Empower
  • Topspin
  • Lab solution
  • LIMS
  • Module 16: 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.

    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 Pharmaceutical Quality Assurance and Quality Control by Faculty of Good Manufacturing Practice, 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, healthcare like Johnson & Johnson, Roche, Novartis, Merck & Co., AbbVie, GlaxoSmithKline, Pfizer, Sanofi, Bayer, Eli Lilly & Co., Novo Nordisk, Teva Pharmaceutical Industries, Dr. Reddy’s Laboratories, Lupin Limited, Torrent Pharmaceutical Ltd., Cipla Limited, Emcure Pharmaceuticals, Sun Pharmaceutical Limited, Mankind Pharma, Ajanta Pharma, IPCA Laboratories etc. The IGMPI’s Corporate ResourceDivision actively recommends our students and training participants for various jobrequirements and specialized roles to Human Resource, Talent Acquisition as well as the headsof various departments in Pharmaceutical, Healthcare industries on regular basis.

    Future career prospects of Pharmaceutical QA & QC Training

    QA & QC are quite essential parts of pharmaceutical, biotech and all other verticals of the healthcare industry. the two find application in other industry types as well but since healthcare is the most dynamic industry and the one concerned with health and well-being of the population, QA & QC are highly treated and most regarded divisions to settle in. thus the career prospects and opportunities are never ending.

    With this important role in the industry, sense of responsibility is expected from the joining employee and of programme a thorough and complete knowledge of the work area. Our online programme works to prepare candidates for the same. The interactive online programmes thus has been tailor made to suit needs of employed as well as yet to be employed candidates targeting to take over the quality assurance and quality control divisions of the industry.


    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

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