Life Science Consulting Pvt Ltd (LSCPL) in association with its parent Convalgroup with global offices supporting over 200+ CSV projects across Americas, Europe and APAC/India will soon start Conval Academy in India which will offer basic and advanced level courses in Computerized System Validation (CSV).
The course will be launched for pharmacy and IT professionals, working in the pharma industry or wishing to enter the industry, on January 13 at the function organised by Indian Pharmaceutical Association, (IPA) Maharashtra state branch. Arjun Guha Thakurta, director- operations, LSCPL will deliver the introductory speech about CSV. So far CSV is not part of the pharmacy/IT curriculum in the country. Scores of aspiring pharma professionals /existing professionals including pharmacists/IT professionals will benefit from the course spanning over several modules.
In the present environment of “GXP Compliance”, pharmaceutical companies are facing challenges due to scarcity of trained personnel, having skills and capability of performing CSV. CSV typically is the integrated responsibility encompassing Quality Assurance (QA), Regulatory Affairs (RA) and Information Technology (IT). If students are trained in CSV upfront, then apart from their own career prospects, Indian pharmaceutical industry will be benefited with their special expertise.
The course will be supported by Convalgroup strategic partners in education Academia Life Sciences Center (ALSC), Turkey, Indian Pharmaceutical Association (IPA) and various premier institutions of pharmacy in India. Candidates pursuing final year B. Pharm, M. Pharm, and working pharmacists, IT students/professionals are eligible to attend the basic course on CSV.
The six-month long basic CSV course, will be on par with global educational standards and shall delve into various aspects of validation including various key Global regulations like 21 CFR Part 11, 21 CFR 211.68 for US and EC Annex 11 applicable for Europe and compliance with various other global regulatory requirements. The course will provide attendees hands on experience on executing real-life scenarios in CSV through workshops. The course will be conducted by a team of experts from Life Science Consulting and Convalgroup global HQ in India. A detailed study materials will be provided to the students. They will also be allowed to access the resource-rich library of Conval Academy for self-study and enhance their understanding CSV and related activities.
The Advanced Course on CSV will be completely online over a highly interactive MS Office 365 platform and highly modular and focus on specific workstream for specialization for example, SAP-ERP validation, LIMS (Laboratory Information Management System) validation, CDS (Chromatographic Data System) validation, BMS (Building Management System) validation, Track and Trace System Validation, Network Qualification, Critical Equipment Qualification (eg. WFI (Water For Injection, HVAC, LAF System). The advanced courses study materials will leverage the real-life implementation experience and train the pharmacist to play the role of a Project Manager or a Project Quality Manager or a Training Manager or a Documentation Manager and allow him access to full lifecycle documentation templates for the specific workstream he or she selects for the course. Once a candidate completes any course, a formal test will be conducted for evaluation of the candidate and Certificate of Course Completion will be issued by Convalgroup, said Arjun Guha Thakurta.
The Academy will focus currently in Mumbai and gradually expand the courses to other pharmacy colleges in the country supported by Indian Pharmaceutical Association (IPA).
Talking about importance of CSV in India, Thakurta says “CSV in various forms (from the much simpler excel sheet validation to highly complex track and trace validation) will continue to be a key resource shortage for Indian pharma companies exporting to regulated markets such as USA, EU etc. The exporting companies need to comply with the likes of 21 CFR Part 11 (US FDA), EC Annex 11 (EU) norms. Apart from candidates getting recruited by pharma companies, high-end consulting global firms like Deloitte, Ernst & Young, KPMG, McKinsey etc. and may also be highly sought after by IT Majors like Infosys, Accenture and Cognizant who currently support many of the world’s largest pharmaceutical companies from India.”