On the Job Training In Pharma

On-the-job training (OJT) in the pharmaceutical industry is an integral part of professional development for new hires or employees transitioning into new roles. It is designed to help individuals acquire specific skills, knowledge and competencies needed for their responsibilities in a highly regulated and technically demanding environment.

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CFR 211.25?? Personnel qualifications say:

“Every person engaged in the production, processing, packaging, or holding of pharmaceuticals shall have education, training, and experience, or any combination thereof so that the person can perform the assigned functions.”?

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Key Features of Training in Pharma

1. Compliance and Regulatory Focus Training on Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Understanding FDA, EMA, and other regulatory guidelines. Documentation standards and audit preparedness.
2. Hands-on Experience Operation of specialized pharmaceutical equipment. Handling, storage, and transportation of raw materials and finished products. Performing analytical and quality control tests.
3. Role-Specific Training Manufacturing Roles: Training on production line procedures, batch records, and equipment sterilization. R&D Roles: Laboratory techniques, experiment design, and data analysis. Quality Assurance/Quality Control: Methods for testing purity, potency, and stability of products.
4. Soft Skills Development Team collaboration in cross-functional environments. Communication skills for documentation and reporting. Problem-solving and decision-making in compliance-critical scenarios.
5. Mentorship and Supervision Training under experienced professionals to ensure adherence to safety and quality standards. Frequent performance reviews and feedback for continuous improvement.
6. Safety and Risk Management Training on handling hazardous materials and waste management. Emergency procedures for spills, contamination, or other incidents.

Benefits of OJT in Pharma

• Faster skill acquisition with practical exposure.
• Improved retention of knowledge compared to theoretical learning.
• Alignment of employees with organizational practices and culture.
• Immediate application of learning in a controlled environment.

Examples of on the Job training in Pharma

1. Production Operators: Learning to operate tableting or capsule-filling machines.
2. Analytical Chemists: Gaining proficiency in techniques like High-Performance Liquid Chromatography (HPLC) or Mass Spectrometry.
3. Regulatory Affairs Specialists: Training on dossier preparation and submission for drug approvals.
4. Quality: Workshops on recent trends in pharma sector and additional Quality checks.

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How to make Training more effective

Assessment and Evaluation of Training:-?

There are several assessment methods to evaluate knowledge, skills and attitudes, Oral examination, written examination (using paper or computer systems), Simulations (actual or virtual using computers), Performance-based assessment. “Self-assessments” are used frequently in self-study and computer-based courses to give the trainee a chance to evaluate how much they have learned. Self-assessment can be recorded with a form which can be documented for further evaluation.

Training Feedback:-?A training program can be evaluated on the basis of feedback collected from the attendees regarding the training pattern, trainers, topics, facilities provided, materials provided etc. Combination of questionnaire and feedback form will lead to know and understand the quality of a training program as well as the trainer himself for a better evaluation.

Retraining:-?Remedial training is given when there is evidence that the original training was not adequate, resulting in a person who cannot correctly, safely, effectively or efficiently perform the task. Remedial training is frequently used incorrectly as corrective actions for deviations or failures.

Periodic Review of Training:-?The top management team shall review the training program with personnel department periodically. Also, department head shall review the Individual Training Plan with the employees periodically to ensure that the plan has been completed for satisfactory performance of the functions employees expected to perform.

Training Records, Documentation and Retention:- Training records provide the evidence that the training was carried out. Quality assurance should audit training records periodically. User department will be responsible for preparation of training planner, verify the training records of the entire employee as per their job description, keeping and maintaining a copy of training planner.?

Effective OJT programs in pharma bridge the gap between academic knowledge and industrial applications, ensuring employees are well-prepared for their roles while maintaining high standards of safety and compliance.