On-the-Job Qualification (OJT) & Practical Assessments in Validation Training Effective On-the-Job Qualification and Practical Assessment Framework for Validation Personnel Introduction Validation activities in pharmaceutical manufacturing require hands-on proficiency and deep regulatory understanding. While classroom and theoretical training form the foundation, on-the-job qualification (OJT) and practical assessment ensure that employees can apply knowledge under GMP conditions. This article provides a structured approach to implementing OJT programs aligned with regulatory guidelines from FDA, EMA, and WHO. Regulatory Expectations for OJT Regulatory bodies require documented evidence that employees are trained and qualified to perform validation tasks. Key references include: 21 CFR 211.25(a): Each…