Industry Certificate in  Computer System Validation

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 and healthcare 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

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

Minimum duration to complete this programme is 3 months and maximum is 6 months

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.

• – 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 Industry Certificate in Computer System Validation by Faculty of Good Manufacturing Practice, IGMPI. For all the above mentioned modules elaborate programme material, self-assessment assignments and project work details would be provided by the Institute from time to time. 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 in 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 and IT giants like TCS, Accenture, Cognizant, HCL, Wipro, Pfizer, Sun Pharmaceuticals Ltd, Baxter, IQVIA, Bharat Serums, Syngene International, Piramal Group, Novo Nordisk, Biophore Pharma, Bioclinica, Merck, PPD etc.

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.

Download Prospectus

Programme Fee Details

How to apply

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

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