Training Needs Assessment to Improve Regulatory Compliance and Professional Competency in the Pharmaceutical Industry

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Nayak, A
Pai, G
Thunga, G
Khan, S
Pai, R
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2022
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Vienna, Austria

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Objectives The current Good Manufacturing Practices nonconformances in the pharmaceutical industry are rising because of the lack of skills and competence of the employees. Recruiting adequately qualified fresher graduates possessing industry-required skills is important. The study aimed to conduct the need assessment survey among pharmacy postgraduate students, academicians from pharmacy colleges, and industrial experts and a qualitative in-depth interview among industry experts to understand the gaps in the professional competency to be acquired in the industrial setup. Methods Need analysis survey was performed using a validated questionnaire. Descriptive analysis was performed using Statistical Package for Social Sciences software. A qualitative one-to-one in-depth interview was conducted using a validated interview guide and was analyzed thematically using N-VIVO 12.0 software. Results A survey was conducted among 234 students, 126 academicians and 137 industrial experts. 93% of students, 88.9 % of academicians, and 94% of industrial experts agreed that there is a lack of knowledge, skills, and professional competency and there is a need for additional training in Food and Drug Administration (FDA) critical and major observations. From an industrial perspective (using qualitative interview) overview of FDA inspections, FDA observations and their impact on the patients in terms of quality, safety, and efficacy and on the industry, handling of nonconformances, data integrity issues, communication, and technical writing were the domains identified for the training. Also, case study discussions on the FDA observations will be effective in problem-solving real-world situations. Conclusions This research emphasizes that there is a need to develop training programs to improve the skills, employability and regulatory compliance in the pharmaceutical industries. Skill-based is an effective learning strategy that will help the students to understand the current industrial expectations, trends, and technologies to bridge the gap between industry and academia.

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Value in Health

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ISPOR Europe 2022

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25

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12

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Public health

Applied economics

Social Sciences

Science & Technology

Life Sciences & Biomedicine

Economics

Health Care Sciences & Services

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Nayak, A; Pai, G; Thunga, G; Khan, S; Pai, R, Training Needs Assessment to Improve Regulatory Compliance and Professional Competency in the Pharmaceutical Industry, Value in Health, 2022, 25 (12), pp. S387-S387