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 course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale. Additionally, this course 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 course is particularly useful to those who interface with vendors, FDA and other regulatory agencies.
Module 1 : Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare industries
Module 2 : Qualification and Validation
Module 3 : Introduction to Computer System 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: Industry based Case studies
Any Life Science graduate/ B.Pharm/M pharm/MSc in science disciplines/BE/BTech(Computers/Electronics/IT) MCA/ any diploma holder or passed outs of Clinical Research degree or diploma courses are eligible for these course. Working professionals of any of the following industry types Drugs manufacturing, Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.
Minimum duration to complete this program is 1 year and maximum is 2 years.
This course is offerred through excellent mix of distance and e-learning.
The registration dates for this bi-annual programme run by the institute are updated timely on the webpage. The Training sessions and webinars are scheduled preferably on weekends depending on the availability of visiting faculty.. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants.
A one-time fees (lump sum paid at beginning of the course) of Rs 23,000 /- (800 USD for oversees students) is mandatory. This covers for the course registration fees, tuition fees, course material fees etc. Apart from this, an examination fee of Rs 450/- (USD 20) per module needs to be paid later as per the examination notification of the Institute. 10% of fee concession is applicable to applicants belonging to SC/ST, Physically Handicapped (PH), Ex-servicemen or those who belong to Economically Weaker Section (EWS)/ Below Poverty Line (BPL).
IGMPI follows a credit system based on all 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 in Computer System Validation. For all the above mentioned modules elaborate course 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.
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, healthcare and IT Companies like QuintilesIMS, Tata Consultancy Services, Infosys, Wipro, Immunomedics, HCL, Congnizent, Accenture, Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Bliss GVS Pharma, Al Rawabi, SeQuent, PepsiCo India, Mankind, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy, Biocon etc.
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 course, professionals can work as computer system validation specialist, validation engineer, validation consultant/analyst, QA consultant, IT validation analyst.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like