Standard Operating Procedure for Periodic Refresher Training on Regulatory SOPs
| Department | Regulatory Affairs |
| SOP No. | RA/2026/790 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 18/04/2026 |
| Effective Date | 18/04/2026 |
| Review Date | 18/04/2028 |
Purpose
This Standard Operating Procedure (SOP) establishes the guidelines and controls for conducting periodic refresher training on Regulatory Standard Operating Procedures to ensure continuous compliance, maintain regulatory knowledge, and reinforce quality management practices across all relevant departments. The objective is to support ongoing employee competence and awareness regarding regulatory governance, ensuring sustained adherence to regulatory requirements, minimizing compliance risks, and promoting a culture of continuous improvement within the organization.
Scope
This SOP applies to all Regulatory Affairs personnel and any cross-functional staff involved in regulatory documentation, submission management, compliance activities, and regulatory governance processes. It encompasses all regulatory SOPs that require periodic refresher training, including but not limited to documentation control, submission procedures, compliance monitoring, and quality systems related to regulatory operations. The SOP excludes initial training of new employees, which is governed under separate induction training SOPs, and training related to non-regulatory functional areas.
Responsibilities
The following roles are involved in the execution and oversight of this SOP:
- Training Coordinator: Plans, schedules, and records refresher training sessions, maintains training logs, and communicates training schedules to applicable personnel.
- Regulatory Affairs Trainers: Develop and deliver refresher training content, assess participant understanding, and update training materials as needed.
- Department Heads: Ensure their team members attend scheduled refresher training and comply with SOP requirements.
- Quality Assurance (QA): Reviews training effectiveness, audits training records for compliance, and escalates non-compliance issues.
- Employees: Attend refresher training sessions as scheduled and apply learned procedures in their daily activities.
Accountability
The Head of Regulatory Affairs holds overall accountability for the implementation, compliance, review, and continuous improvement of this SOP. This includes ensuring the refresher training program meets regulatory and internal quality requirements, conducting periodic effectiveness reviews, and escalating issues impacting training effectiveness or regulatory compliance to senior management.
Procedure
1. Training Planning and Scheduling: The Training Coordinator shall maintain a master list of all regulatory SOPs requiring periodic refresher training. Based on risk assessment, regulatory requirements, and internal policy, define training intervals (e.g., annually or biennially). Prepare and circulate a training calendar to affected departments at least one month in advance.
2. Preparation of Training Materials: Regulatory Affairs Trainers shall review current SOPs and update training content to reflect any revisions, regulatory changes, or common non-compliance areas identified in audits. Training materials shall be validated for accuracy and relevance prior to sessions.
3. Notification and Attendance Confirmation: The Training Coordinator will notify participants via email or internal communication channels with training dates, venues, and agendas. Attendance lists will be prepared, and participants must confirm their availability or request rescheduling due to operational needs.
4. Conducting Training Sessions: Training sessions shall be conducted in a controlled environment, preferably classroom or webinar format. Trainers will deliver content, engage participants through interactive discussions, and clarify doubts. Sessions shall include a review of key SOP provisions, updates, and practical implications.
5. Assessment and Feedback: Upon completion, participants shall complete a knowledge assessment—either written or electronic—to confirm comprehension. Trainers will review assessments to identify any common gaps or misunderstandings. Feedback on training effectiveness shall be collected from attendees to improve future sessions.
6. Documentation and Record Keeping: Attendance sheets, training materials, assessment results, and feedback forms shall be compiled and stored in a dedicated training records folder within the document management system. Records must be retained as per company and regulatory retention policies.
7. Non-Attendance and Follow-Up: Any personnel missing the scheduled refresher training without valid excuse shall be escalated to their Department Head. Make-up training shall be organized within 30 days. Continuous non-compliance shall trigger disciplinary review and corrective action.
8. Review and Continuous Improvement: The Head of Regulatory Affairs will review refresher training effectiveness annually, considering audit findings, regulatory updates, and participant feedback. Necessary changes to the training schedule, content, or delivery methods shall be implemented and documented as SOP revisions.
This procedure ensures all personnel maintain up-to-date knowledge of regulatory requirements and SOP changes, thereby safeguarding compliance and quality within the regulatory affairs function and associated departments.
Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- Regulatory Affairs (RA): Department responsible for regulatory compliance and submissions
- GMP: Good Manufacturing Practice
Documents
The following documents are required for the effective implementation and documentation of this SOP’s activities:
- Periodic Refresher Training Schedule and Attendance Register (Annexure-1)
- Regulatory SOP Refresher Training Material and Assessment Questionnaire (Annexure-2)
- Training Feedback and Evaluation Form (Annexure-3)
References
- ICH Q10 Pharmaceutical Quality System
- FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- EU GMP Guidelines – Annex 16: Certification by a Qualified Person and Batch Release
- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- Internal Quality Management System Procedures and Training Policies
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Periodic Refresher Training Schedule and Attendance Register
Purpose: To document scheduling and attendance for periodic refresher training on regulatory SOPs ensuring compliance and completeness of training records.
| Date | Training Topic | Department | Trainer | Attendees | Attendance Status |
|---|---|---|---|---|---|
| 15/03/2026 | Regulatory Documentation Control | Regulatory Affairs | Trainer A | 15 | 100% |
| 15/03/2026 | Submission Management Updates | Regulatory Affairs | Trainer B | 12 | 92% |
| 15/03/2026 | Compliance Monitoring Procedures | Cross-Functional | Trainer C | 20 | 95% |
Annexure-2: Regulatory SOP Refresher Training Material and Assessment Questionnaire
Purpose: To provide validated training content and confirm understanding of regulatory SOP requirements through participant assessment.
Sample Training Content:
- Overview of Regulatory SOP framework and recent updates
- Documentation control principles and best practices
- Submission process workflow and timelines
- Handling deviations and escalation procedures
- Roles and responsibilities in regulatory compliance
Sample Questions:
- What is the required retention period for regulatory documentation according to SOP?
- Describe the procedure to handle deviations identified during submission preparation.
- Who is responsible for approving regulatory documentation before submission?
- Explain the process for periodic refresher training compliance tracking.
Annexure-3: Training Feedback and Evaluation Form
Purpose: To capture participant feedback on the training session content, delivery, and overall effectiveness for continual improvement.
| Parameter | Rating (1-5) | Comments |
|---|---|---|
| Relevance of Content | 4 | Well-aligned with current regulatory challenges. |
| Clarity of Presentation | 5 | Trainer explained concepts clearly. |
| Training Duration | 3 | Could be slightly shorter. |
| Interaction and Engagement | 4 | Good opportunities for Q&A included. |
| Overall Satisfaction | 5 | Informative and practical session. |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 18/04/2026 | 1.0 | Initial issue | New SOP creation |