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: Qualification & Validation
Module 2: Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP & 21 CFR Part 11) and documentation
Module 3: Implementation in Life science verticals
Module 4: GAMP 5 and documentation
Module 5: Importance and Principle of Data Integrity
Module 6: Case Studies
Any Life Science graduate/ B.Pharm/M pharm/MSc/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.
The candidate is expected to complete the course in 3 months.
The candidate is expected to complete the course in 3 months.
The registration dates for this programme run by the institute are updated timely on the webpage. 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.
The mandatory course fee (one-time payment) for the distance cum e learning mode is Rs. 21,000/- (700 USD for overseas students). 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.
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 online exam and are also obliged to submit assignments after each module. After successful completion the participants will be awarded Certificate in Computer System Validation. For all the above mentioned modules elaborate course material, assignment and case studies 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 food giants like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon 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 and Food industries on regular basis.
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