Compliance with international standards for labeling and relabeling of medical devices requires a highly skilled workforce. This guide outlines the mandatory training protocols for personnel at Aika Ceuticals, Lahore, ensuring all medical device handling meets strict regulatory and safety benchmarks.
1. Purpose
The primary purpose of this procedure is to establish a robust framework for the training and development of personnel. This ensures that every team member involved in the labeling and relabeling of medical devices possesses the technical competency to maintain product integrity and regulatory compliance.
2. Scope
This SOP applies to the professional development and operational training of all staff members at Aika Ceuticals, Lahore, specifically those tasked with the documentation, marketing, and physical handling of medical device labeling.
| Role | Responsibility |
| Department Head (DH) | Identifying specific training needs related to device labeling; coordinating with Admin and the CEO for resource allocation. |
| Admin Department | Maintaining comprehensive training records and schedules. |
| Personnel | Actively participating in on-the-job training and adhering to relabeling protocols. |
4. Operational Procedures for Medical Device Training
4.1 General Training Requirements
Before beginning tasks related to the labeling and relabeling of medical devices, all new employees must undergo specialized orientation.
- On-the-Job Training: Must be closely monitored by the Department Manager (DM).
- Regulatory Literacy: Employees must demonstrate a basic understanding of local and international regulatory requirements for medical devices.
4.2 Product-Specific Labeling Training
Marketing and technical personnel must undergo comprehensive in-house training to master product specifications.
- Knowledge Development: Focuses on accurate labeling claims and device symbols.
- Global Standards: Personnel may be sent abroad for training by Foreign Principals to align with international relabeling standards.
- Annual Refreshers: Mandatory yearly updates to account for new medical device regulations.
4.3 Handling Customer Complaints
Training includes identifying what constitutes a "complaint" regarding device labeling and the formal procedure for reporting and corrective action.
4.4 Documentation & Material Retention
- Records: All training sessions regarding labeling protocols are documented by the Manager/Trainer and filed by Admin.
- Training Materials: All manuals and reference guides must be retained in a retrievable format for audit purposes.
4.5 Performance Appraisals
Annual appraisals are used to identify gaps in an employee's knowledge of medical device labeling. Agreed-upon development needs are communicated and filed in the personnel record.
5. Training Methods for Medical Device Excellence
To ensure high-quality standards in the relabeling of medical devices, Aika Ceuticals employs diverse training methodologies:
- Hands-on Product Training: Physical interaction with devices and labels.
- Coaching: Direct on-the-job mentorship.
- Self-Evaluation: Periodic testing of regulatory knowledge.
- External Training: Specialized workshops hosted by regulatory bodies or foreign partners.
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