Shortcoming in the quality of the product results in the “commercial software engineering lacks the controls needed to maintain the efficacy of product. It is important to ensure the workforce follows proper software development and sustainment practices for the manufacturing of the product. To ensure the reliable intended performance and to make the record compliance, validated computer programmes are required which enforces a structured, well-defined execution of the task. Pharmaceutical computer system validation is a provision to convey the quality to the system.
Pharmaceutical Computer Software Assurance is a skeleton for the design of the Computer System Validation. It 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. CSA accentuate is on expository thinking, risk management, patient and product safety, data integrity and quality assurance.
This course will be of benefit to anyone involved in FDA audits and Computer Software Assurance (CSA) on both a domestic and global scale. Additionally, this course will be tremendously relevant to candidates in Quality Assurance, Compliance, Procurement, Informatics, Validation, R&D, Commercial, Quality Control and other job functions which are influenced by CSA efforts. This course is particularly useful to those who interface with vendors, manufacturing, FDA and other regulatory agencies.
Module 1: Quality, Quality Assurance and Quality Control in pharmaceutical industry
Module 2: Qualification and Validation
Module 3: Computer System Validation
Module 4: Introduction to Computer Software Assurance
Module 5: FDA Regulatory Compliance for Software Assurance
Module 6: Impact on Data Integrity of Quality System
Module 7: FDA Inspections & Warning Letters (A case study based approach)
Any Graduate/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.
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 online learning tools incorporated into the design of the webpage make the course lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.
A comprehensive study material for all the modules in hard copies ensuring the needs of the participants. The accompanying training material is appropriately aligned with the current Industry’s expectations.
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 course, usually after every module) and appear for an online exam at the end of the course.
After successful completion, the participants will receive a Certificate in Computer Software Assurance by IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular & part time modes), elaborate course material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.
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 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 must assure for their information technologies (such as computer systems and software that run on them and also the infrastructure components) to be efficient to meet the intended business needs. Industries focus on the accuracy of documents, speed, inspections, audit and complying with the regulations. There is a bright career path if one is willing to learn about personnel process and technologies.
Computer Software Assurance provide an explosive growth for professionals, software vendors and developers, research, development and manufacturing associates and scientists, healthcare and clinical professionals, quality management professionals and technical project managers to steadily grow as technology evolves and regulations progress. After completion of this course, professionals can work as software quality assurance analyst, software tester, Information system analyst, computer system analyst, manufacturing quality assurance and quality assurance manager.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like