Prospectus

The Institute of Good Manufacturing Practices India, an autonomous Institute recognised by Ministry of Commerce & Industry, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI), presents a unique, friendly and interactive platform to get rid of all your GMP compliance related issues. GMP—an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing and sustainability services—in itself is the most dynamic part which witnesses frequent changes in terms of new rules being added and old ones being renewed. Thus, keeping oneself updated with current GMPs is essential to remain aligned with evolving industry requirement and standards.

Our team comprises knowledgeable professionals from diverse sectors such as Pharma, Healthcare, Food, Nutraceutical, and Nutrition industries, pooling together their expertise, know-how, and experiences to create this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better education and training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food & Nutrition, Environment and Healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Good Laboratory Practice and Product Management. Keeping pace with the digital era, IGMPI has also expanded into the domains of Geoinformatics, Remote Sensing, Cybersecurity, Information Security, and Network Security, preparing learners to address the growing need for secure and resilient information systems as well as advanced geospatial solutions.

Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which include GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), Good Laboratory Practice, Information Security Compliance and Remote Sensing. These are delivered in the form of formal classroom studies, online/interactive programmes, online seminars, and onsite training programmes, along with insights into global industry practices. In short, a round-the-clock service is provided for any information in these areas required by anybody from around the country and abroad.

Based on high standards of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC have been approved by the Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. IGMPI is duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018.

The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:

    1. Course Content
    2. Course Design
    3. Course Material
    4. Instructors
    5. Class size & Attendance
    6. Facilities
    7. Evaluation of Students
    8. Written Examination
    9. Certificate

IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.

IGMPI is also approved by Sector Skills Council under National Skill Development Corporation (NSDC) setup by Ministry of Skill Development & Entrepreneurship, Govt of India (TC ID:TC342267).

IGMPI has been conferred with the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023". QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.

Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.

Computer System Validation (CSV) is no longer viewed merely as a regulatory compliance requirement in the pharmaceutical and life sciences industry. In today’s digital and highly regulated environment, CSV plays a critical role in ensuring data integrity, patient safety, product quality, and operational excellence across computerized systems.

An effective validation approach not only minimizes regulatory and compliance risks but also enhances system understanding during implementation and throughout the system lifecycle. Modern CSV practices, aligned with current FDA guidance, GAMP 5 (2nd Edition), Data Integrity principles, and Computer Software Assurance (CSA) concepts, promote a risk-based, efficient, and scientifically driven validation strategy.

Computer System Validation provides organizations with a valuable opportunity to evaluate and optimize computerized systems for improved efficiency, reliability, compliance, and business performance. A well-executed CSV programme can significantly reduce operational errors, improve audit readiness, strengthen electronic records management, and save both time and cost through structured project execution.

Subject Matter Experts (SMEs) in CSV play a vital role in implementing compliant and sustainable digital systems by bridging quality, regulatory, technical, and business requirements. Their expertise is essential in validating systems such as LIMS, QMS, ERP, MES, eQMS, SCADA, cloud-based applications, AI-enabled systems, and other GxP-regulated platforms used across the pharmaceutical industry.

This programme is designed to benefit professionals involved in FDA, MHRA, EU GMP, WHO, and global regulatory inspections and Computer System Validation activities on both domestic and international levels. It is highly relevant for professionals working in Quality Assurance, Quality Control, Regulatory Affairs, Validation, IT, Informatics, Manufacturing, Engineering, Clinical Research, Pharmacovigilance, Procurement, R&D, and Compliance functions.

The programme is particularly valuable for individuals interfacing with software vendors, auditors, regulatory agencies, and cross-functional project teams responsible for implementing, managing, and maintaining validated computerized systems in GxP environments.

 Programme Module

Module 1: Quality, Quality Assurance and Quality Control in Pharmaceutical Industries

• Basics of Quality
• GMP Regulations: USFDA, EU, TGA, ICH, WHO
• Need of Quality
• Introduction to QA and QC

Module 2: Foundations of CSV

• Introduction to Computer System Validation
• Importance of Computer System Validation (CSV) in Pharma GMP & Quality
• Qualification & Validation
• Overview of regulated industries (Pharma, Biotech, Medical Devices)
• Key terminologies in CSV
• Evolution of validation practices
• Lifecycle approach in validation
• Introduction to GxP concepts
• Roles and responsibilities in CSV
• Overview of validation deliverables

Module 3: Regulatory Framework & Compliance

• Regulatory requirements for software validation – 21 CFR Part 11
• EU Annex 11 overview
• Comparison: US FDA vs EU regulations
• Quality certifications, Government regulations, ICH guidelines and ISO 9000
• Data integrity regulatory expectations (ALCOA++)
• FDA guidance on validation
• MHRA data integrity guidelines
• WHO validation guidance
• Regulatory inspection readiness
• Common regulatory observations (483s, warning letters)

Module 4: Software Development Life Cycle (SDLC)

• Software Development Life Cycle (SDLC)
• SDLC models (Waterfall, Agile, V-model)
• Validation in Agile environments
• Requirement gathering and analysis
• Functional and Design specifications
• Configuration management
• Change control in SDLC
• TestingstrategiesinSDLC
• Traceabilitymatrix
• SDLCdocumentation 

Module 5: GAMP 5&Documentation

• GAMP5 and documentation
• GAMP5 principles and framework
• GAMP categories of software
• V-model in GAMP5
• Supplier assessment and vendor audits
• Documentation lifecycle
• User Requirement Specification (URS)
• Functional Specification (FS)
• Design Qualification (DQ)
• Validation Master Plan (VMP) 

Module 6: Risk-Based Validation

• Risk based approach to software quality and Validation
• Introduction to risk management (ICH Q9)
• Risk assessment methodologies (FMEA, HACCP)
• Risk ranking and filtering
• Risk control strategies
• Risk review and monitoring
• Critical vs non-critical systems
• Impact assessment
• Risk-based testing approach
• Risk documentation 

Module 7: Testing & Qualification

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Test planning and protocols
• Test case design
• Test execution and deviation handling
• Regression testing
• User Acceptance Testing (UAT)
• Validation reporting
• Revalidation strategies
• Validation Master Plan
• Qualification Protocols: DQ, IQ, OQ, PQ, Calibration and Maintenance

Module 8: Data Integrity & Governance

• DataGovernance&Risk ManagementinDataIntegrity
• Datalifecycle management
• Dataintegrityprinciples (ALCOA++)
• Audittrailsandtheirimportance
• Digitalrecordmanagement,audittrails,andprocessmapping
• Electronicsignatures
• Datasecurityandaccesscontrols
• Backupanddisaster recovery
• Dataarchivalandretention
• Dataintegrityriskassessments 

Module 9: Audits & Inspection Readiness

• Software Quality Audit
• Types of audits (internal, external, regulatory)
• Audit planning and execution
• Audit trails review techniques
• Handling audit observations
• CAPA (Corrective and Preventive Actions)
• Inspection readiness strategies
• Mock audits and best practices
• Digital record management, audit trails, and process mapping

Module 10: Emerging Technologies & Digital Transformation

• DigitalTransformationwithAdvanced&EmergingTechnologies:AI/ML,dataintegrity by design
• IntroductiontoAI/ML inregulatedenvironments
• ValidationchallengesinAI/ML systems
• Dataintegritybydesignprinciples
• Cloud computing in CSV
• SaaS,PaaS,IaaSvalidationconsiderations
• Cybersecurityinvalidatedsystems
• Blockchainindataintegrity
• Industry4.0 andPharma4.0
• Digitaltwins in validation 

Module 11: Computer Software Assurance (CSA)

• New Approach to CSV – Computer Software Assurance (CSA)
• FDA CSA guidance overview
• Differences between CSV and CSA
• Critical thinking in CSA
• Risk-based assurance approach
• Documentation simplification in CSA 

Module 12: Automation & Advanced Systems

• Intelligent Automation & Robotic Systems
• Robotic Process Automation (RPA) in CSV
• Validation of automated workflows
• SCADA and PLC validation basics
• Laboratory Information Management Systems (LIMS) validation
• ERP systems validation (e.g., SAP)

Module 13: Industry based Case studies

• IndustrybasedCasestudiesinCSV(DataIntegrity,AuditTrails,etc.)
• Casestudy: FDAwarning letter analysis
• Casestudy: Data integrity breach
• Casestudy:Audittrail failure
• End-to-endvalidationproject walkthrough
• FuturetrendsinCSVandcareerpathways

Module 14: 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 obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will be awarded Post graduate Diploma/Executive Diploma in Computer System Validation 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

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 professionalsworking with global pharmaceutical like Cognizant, Accenture, Deloitte, Gland Pharma, Novo Nordisk, Pfizer, IQVIA, Baxter, Novartis India, Jubilant Generics Limited, Sun Pharmaceutical Industry, Merck Group, Bayer, Torrent Pharmaceutical Ltd., Eli Lilly & Co., GlaxoSmithKline, IPCA Laboratories, Tata Consultancy Services, Johnson & Johnson, Cipla Limited, 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 Computer System Validation

Companies, particularly the life science industries must validate their information technologies (such as computer systems, software that run on them and infrastructure components) to ensure they meet the intended business needs. Computer System Validations involve activities primarily around generating requirements and specification documents, testing the systems against those specifications, documenting test results and writing final reports. There is definitely a bright career path if one is willing to learn about personnel process and technologies.
Computer System Validation field had enjoyed an explosive growth since the early 90’s. IT professionals, software vendors and developers, research, development and manufacturing associates and scientists, healthcare and clinical professionals, quality management professionals and technical project managers are dedicated to this field and the need is steadily growing as technology evolves and regulations increase. After completion of this programme, professionals can work as computer system validation specialist, validation engineer, validation consultant/analyst, QA consultant, IT validation analyst.