Computer validation is more than a compliance requirement. It not only reduces regulatory risk, but it also increases understanding of system during project implementation and enforces a structured, well-defined execution of the project. Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality, with the potential to save cost and time. Subject matter expert (SME) of CSV will have a major role in achieving these benefits. This programme will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale. Additionally, this programme will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts. This programme is particularly useful to those who interface with vendors, FDA and other regulatory agencies.

Programme Modules

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

Module 2 : Introduction to Computer System Validation

Module 3 : Qualification and Validation

Module 4 : Software Development Life Cycle (SDLC)

Module 5 : Regulatory requirements for software validation-21 CFR Part 11 (A detailed analysis of USA and EU perspectives.)

Module 6 : Software Quality Audit

Module 7 : Risk based approach to software quality and Validation

Module 8 : GAMP 5 and documentation

Module 9 : Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000

Module 10: FDA Inspections & Warning Letters (A case study based approach)

Module 11: Importance and Principle of Data Integrity

Module 12: Developing the Data Integrity Plan and Guidance document on Data Integrity

Module 13: New Approach to CSV - Computer Software Assurance (CSA)

Module 14: Industry based Case studies 

Eligibility

Graduate in any discipline is eligible for our Post Graduate Diploma and Certificate Programmes. For Executive Diploma programmes and Professional Certifications, you need to have at least 1 year of work experience.

Programme Duration

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

Programme Mode

Registrations are currently open for regular and online 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.
• – 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 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 receive a certificate of Post graduate Diploma/Executive Diploma in Computer System Validation, 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 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.

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Programme Fee Details

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free),  Phone: +91 11 26512850

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