Guidelines for Pharmacovigilance Training Records Management

1) Purpose

The purpose of this SOP is to outline procedures for managing training records related to pharmacovigilance activities.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for training and development, including pharmacovigilance managers, trainers, and compliance officers.

3) Responsibilities

The Training Records Management Team is responsible for maintaining accurate and up-to-date training records to ensure compliance with regulatory requirements and organizational standards. The Pharmacovigilance (PV) Manager oversees training records management activities to ensure competence and proficiency among pharmacovigilance staff.

4) Procedure

4.1 Training Needs Assessment

1. Conduct periodic assessments to identify training needs based on regulatory updates, organizational changes, and performance gaps.
2. Collaborate with department heads and managers to determine training priorities and objectives.
3. Document training requirements and develop a training plan aligned with pharmacovigilance goals and compliance obligations.

4.2 Training Program Development

1. Design and develop training programs and materials tailored to specific pharmacovigilance roles and responsibilities.
2. Incorporate adult learning principles and interactive methods to enhance learning effectiveness.
3. Review and update training content regularly to reflect changes in pharmacovigilance practices and regulatory requirements.

4.3 Training Delivery and Evaluation

1. Deliver training sessions through various formats, including classroom sessions, workshops, e-learning modules, and on-the-job training.
2. Assess participant learning through quizzes, assessments, and evaluations.
3. Collect feedback from participants and stakeholders to improve training delivery and content.

4.4 Training Records Documentation

1. Maintain comprehensive records of training activities, including attendance sheets, training evaluations, and completion certificates.
2. Ensure training records are accurate, complete, and accessible for audits and inspections.
3. Archive training records in compliance with regulatory retention requirements and organizational policies.

4.5 Training Effectiveness Monitoring

1. Monitor and evaluate the effectiveness of training programs based on predefined metrics and performance indicators.
2. Identify areas for improvement and implement corrective actions to enhance training outcomes and participant satisfaction.
3. Report on training effectiveness and compliance to management and regulatory authorities as required.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Training plans, training materials, attendance records, training evaluations, completion certificates.

7) Reference, if any

EU Good Pharmacovigilance Practices (GVP) Module VIII – Training of PV Personnel, FDA Guidance for Industry – Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects.

8) SOP Version

Version 1.0