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

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 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.

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

• Qualitative and Quantitative techniques
• Analytical and Bioanalytical methods
• Titrimetric, Electrochemical, Spectroscopic and Chromatographic techniques

Module 15: Software Based Analysis 

• Empower
• Topspin
• Lab solution
• LIMS

Module 16: Industry Based Case Studies

Module 17: Capstone Project

Eligibility

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma and Professional Certifications Programmes. 10+2 pass-outs are eligible for our Under Graduate Diploma and Diploma holders of two to three years course duration are also eligible for the PG Diploma.

Programme Duration

The minimum duration to complete the PG diploma programme is 12 months and maximum is 24 months. The minimum duration to complete the executive diploma programme is 6 months and maximum is 12 months.

Programme Mode

Registrations are currently open for regular and Part-time (Online Live Classes) both modes.

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.
• Part-time (Online Live 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

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 IGMPI. For all the above-mentioned modules, Part-time (Online Live Classes) 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.

Discipline in Classes and Examination

Every student is required to observe a disciplined behaviour during her/his classes, assessments & examinations and to follow instructions from the Professors. Any act of indiscipline may result into discredit & it will be mentioned in her/his academic report.

Placement Assistance & Corporate Relations

For the Post Graduate Diploma and Undergraduate Diploma Programmes, we will provide placement assistance after the completion of the programme. The Institute has partnered with many organizations for providing placement assistance to its students. The robust placement cell comprises senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.

In recent months the Institute has witnessed more and more participation from professionals working with global healthcare like , Jhpiego, SELCO Foundation, TATA Foundation, Samarthan NGO, PSI, UNICEF, WHO, HCL Foundation, IPE Global, Optum, PATH, AIIMS, Action against Hunger, Ekta Shakti Foundation, Seva Foundation, India HIV-AIDS Alliance, HLFPPT, Deepak Foundation, Novartis, LalPath Labs Ltd., Fortis Healthcare Ltd., HealthCare Global Enterprises Ltd., Indraprastha Medical Corporation Ltd., Narayana Hrudayalaya Ltd., Piramal Enterprises Ltd., Wockhardt Ltd., Cactus Communications, Public Health Foundations of India, Cytel, Religare Health Insurance Company Ltd., Deloitte, DuPont Sustainable Solutions, Bain & Company, Alvarez & Marsal, McKinsey & Company, 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 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.

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Last date for submitting completed Application Form: 6^th Aug 2026.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in