GMP training procedure for medical device site

Kazi
Last modified: July 27, 2024

Purpose

This GMP training procedure for medical devices outlines the requirements for recruiting, training, and developing personnel at a medical device site.

Scope

This procedure applies to the training and development of all personnel within a GMP site, including the documentation and retention of training records.

Responsibilities

Department managers (DM) are responsible for identifying GMP training needs and maintaining training files.

The department manager is responsible for creating job descriptions and for ensuring that:

– Their employees are sufficiently trained to perform their duties before commencing work.

– Training identified is carried out.

– Appropriate GMP training records are made and supplied to the HR department.

DMs are responsible for evaluating the effectiveness of training activities undertaken.

The Human Resources Manager plays a critical role in our operations by securely and responsibly storing employees’ personnel files.

The originator of the GMP training procedure is tasked with determining and identifying who within the organization requires Document Change Notification (DCN) training.

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Training procedure

i. GMP training requirements

All new employees must be trained to perform their assigned jobs. The DM must closely monitor on-the-job training.

All employees must receive training in the quality management system (QMS), quality policy, and relevant procedures and have a basic understanding of GMP regulatory requirements.

The employee shall receive re-training immediately whenever a QMS training deficiency is discovered.

The SOP will be reviewed for change if multiple training sessions are required for the same issue.

When it is determined that an SOP should be reviewed for change, the review will occur within two weeks or at the next monthly management review meeting, whichever is first.

All employees must receive training and assessment in the Good Manufacturing Practices applicable to the GMP site. Annual refresher training shall be documented.

ii. Customer complaints

All employees must be trained in what constitutes a customer complaint and in the site’s complaint handling procedure.

This must include the importance of forwarding complaints to the regulatory affairs department within one business day of receipt from the customer.

iii. Training documentation

All training shall be documented by the manager or trainer of the employee on the site training Record or the DCN training record. Human Resources will maintain the training records.

iv. Training materials

All training materials must be retained in a retrievable format with an appropriate reference or attached to the training files.

v. Recruitment, induction, and review of training

The education, background, training, and experience of prospective employees shall be considered for the position requirements and the job description.

Department managers (DM) are responsible for ensuring that the assigned employees are trained or otherwise qualified for the assigned position.

Before assigning new jobs or tasks, the DM shall check the QMS training matrix to verify that the employee has the required training or skills to perform the job.

All employees shall be recruited against a job description. Job descriptions shall be date-controlled and acknowledged by the employee.

All relevant qualifications will be verified, and a copy of the original certificate will be taken and held in the personnel file.

vi. Controlled environment

Personnel required to work in a controlled environment or perform special processes shall receive training following specified procedures.

vii. Performance appraisals

Employees shall have an annual performance appraisal, during which training and development needs will be identified, agreed upon, and communicated to the employee.

The performance appraisal shall be kept in the employee’s personnel file. During the annual performance appraisal, the effectiveness of previous training shall be reviewed.

During the performance appraisal, it will be determined if any retraining or refresher training is required, and it will be documented on the appropriate paper-based or online form, depending on the position.

The DM and HR shall approve all training and development that require external training.

The GMP training record will be completed in conjunction with the DM to indicate training requirements and method of validation and will be forwarded to the HR department.

viii. Training methods

Training methods include online training (STT—Self Training Tool), Coaching (on the Job), observation, self-training, self-evaluation, and external training. Other methods may also be used and will be documented.

For web-based training, i.e., Oracle or Trackwise Training, online and computer training through the STT will be used.

Coaching (on the Job) may be done in an individual or group session. The trainer must ensure the training is logged on the employee’s Training record.

The group training form may be copied to the individual’s training file if training is done in a group.

A form shall document self-training/evaluation. It is the employee’s responsibility to ensure they understand and follow the attached documents.

Training may be validated by a paper test/questionnaire or observation.

Where verification is by observation, this must be added to the training record upon a time frame valid for observing the appropriate training.

Where appropriate, external training courses may be identified by individuals/managers.

Recognized training organizations will provide these courses.

The individual/manager will obtain authorization from DM (if applicable), HR, and Management.

The employee’s training file will add a copy of the document/letter showing successful completion.

Training records and documents will be maintained per the documentation retention matrix.

Conclusion

In conclusion, effective GMP training procedures for medical device personnel are essential to ensure compliance with regulatory standards and maintain high-quality production processes.

This training encompasses all employees and focuses on quality management systems, customer complaint handling, and controlled environment protocols.

Department managers are important in identifying training needs, maintaining records, and evaluating training effectiveness.

Regular reviews, re-training, and performance appraisals ensure ongoing competency.

Comprehensive documentation and diverse training methods support the development of a skilled workforce, ultimately contributing to the site’s operational excellence.

Author: Kazi Hasan

Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation.

Kazi has worked with several global pharmaceutical companies to streamline production processes, ensure product quality, and validate operations complying with international regulatory standards and best practices.

Kazi holds several pharmaceutical industry certifications including post-graduate degrees in Engineering Management and Business Administration.