Standard Operating Procedure for Training Program
1) Purpose
The purpose of this SOP is to establish procedures for the development, implementation, and management of a training program to ensure that personnel are competent, qualified, and compliant with job responsibilities within the manufacturing facility.
2) Scope
This SOP applies to all personnel involved in manufacturing, testing, and quality assurance activities within the facility.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Training Coordinator:
Responsible for coordinating and overseeing the training program.
3.2 Department Managers/Supervisors:
Responsible for identifying training needs and ensuring participation of their team members.
3.3 Quality Assurance (QA) Specialist:
Responsible for ensuring training compliance and maintaining training records.
4) Procedure
4.1 Training Needs Assessment:
4.1.1 Identify job roles and responsibilities requiring training.
4.1.2 Assess competency and skill gaps through training needs analysis.
4.1.3 Document training needs assessment findings.
4.2 Training Program Development:
4.2.1 Develop a training plan outlining training objectives, content, and methods.
4.2.2 Include regulatory requirements, job-specific procedures, and safety training.
4.2.3 Obtain approval of the training plan from relevant stakeholders.
4.3 Training Delivery:
4.3.1 Conduct training sessions using qualified trainers and appropriate training materials.
4.3.2 Monitor and evaluate trainee performance and comprehension.
4.3.3 Document training completion and results.
4.4 Training Records and Documentation:
4.4.1 Maintain accurate and up-to-date training records for all personnel.
4.4.2 Archive training records according to established document retention policies.
4.4.3 Provide training records during regulatory inspections and audits as required.
4.4.4 Review and update training records regularly to ensure completeness and accuracy.
4.5 Training Effectiveness:
4.5.1 Evaluate the effectiveness of training programs through feedback and assessments.
4.5.2 Implement corrective actions to address identified gaps or deficiencies.
4.5.3 Continuously improve training programs based on feedback and performance metrics.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
1. Training Plan
2. Training Records
3. Training Evaluation Reports
4. Competency Assessments
7) Reference, if any
1. FDA Guidance on Training in GMP Environment
2. ISO 13485 Medical devices – Quality management systems
8) SOP Version
Version 1.0
