At any pharmaceutical production facility, training records serve as proof that an employee has attended a training program. It supports the quality system by showing that the workforce is properly qualified to perform their responsibilities.
When an audit or a regulatory inspection happens, training records are examined together with SOPs, deviations, CAPA, batch records and qualification papers. An employee might have been compliant with the process for decades, but an absence of documented training and qualification records can become a compliance risk.
In general, a good training system takes three basic questions into consideration: has the employee been trained? Was the training about the right procedure? Was the competence proved where necessary?
Depending on the operations within the pharmaceutical industry, the records may include the following:
Training records show evidence of the training employees undergo before executing assigned tasks.
Moreover, they enable the management to have an idea of:
Typically, the training record should include the following:
- Name or ID of the employee
- Name of the department
- Job designation or title
- Topic of the training
- SOP number or any related document number
- SOP revision number
- Date of the training
- Name of the trainer
- Method of training
- Assessment results, if required
- Confirmation by the employee in writing
- Confirmation by the trainer in writing
- Qualification status
- Automatic retraining or expiry date in certain cases
It is especially important to include the document number and revision for controlled documents.
Personnel trained on SOP-001 Rev.03 cannot automatically claim to have been trained on SOP-001 Rev.04 because the training system must indicate which version was used.
Initial training modules may include information on:
As an example, a QC analyst should have training about analytical methods, instruction for instruments, laboratory documentation, OOS investigations and data integrity; while training of a production operator will be entirely different and will include knowledge about equipment, processing instructions, cleaning, line clearance and documentation.
Hence, the training should depend on the job that the employee has rather than giving everyone the same content.
It matches the employees or job roles to the trainings they are required to complete.
For example:
The matrix should be able to show the trainings that have been finished, are outstanding, are overdue or are not applicable.
A practical tip that is often omitted is the fact that the training matrix should be aligned with the responsibilities of the specific job rather than with departments. Even two people working in the same department may require different training.
The evaluation should address the following issues:
In case retraining is deemed to be necessary, the employee must go through it before starting to perform the activities which are governed by the updated procedure unless the transition process has been documented.
The efficacy of training can be measured by means of:
- The use of tests
- The performance of practical tasks
- The observation of performance of the job
- Oral tests
- Qualification exercises
- An inspection of abnormalities in future performance
- An evaluation carried out by the supervisor
For instance, if the operator has passed the written test on equipment SOP, this does not mean that he or she is capable of operating the equipment properly. In such cases, practical qualifications serve as a better proof of competence.
The level of training evaluation should be proportional
The benefits offered by such systems include:
While an electronic system enjoys a lot of benefits, it still does not comply with the regulations.
An effective system allows the organization to show how:
A good training system does not only include the fact of receiving a signature, but it links job responsibilities, revisions of the SOP, training requirements, competency assessment and ongoing certification.
The best organizations also use training data proactively. For instance, if a company receives many reports of violations, inaccuracies in documentation, mistakes in environmental monitoring or equipment operation, this may indicate that training is not effective enough. In such case, just assigning another training section will not solve the problem. It is necessary to analyze whether the problem is a badly prepared procedure or a lack of practical training, supervision or competency.
The training record should provide an overview of the training experience showing that the necessary person received the adequate training on the given procedure at the necessary time and demonstrated the appropriate level of competency.
When an audit or a regulatory inspection happens, training records are examined together with SOPs, deviations, CAPA, batch records and qualification papers. An employee might have been compliant with the process for decades, but an absence of documented training and qualification records can become a compliance risk.
What are the Employee Training Records?
Employee training records refers to the controlled documents or electronic records that show the status of the training, qualification and competence of the employees.Depending on the operations within the pharmaceutical industry, the records may include the following:
- GMP training
- SOP training
- Job-related training
- Safety training
- Equipment training
- Data integrity training
- Aseptic technique training
- Laboratory training
- Environmental health and safety training
- Refresher training
- Competence and qualification assessments
Why Training Records are Important
The production of pharmaceuticals involves human actions and decisions. Therefore, an incorrect execution of an SOP, improper sampling, equipment operation or flawed documentation can affect product quality.Training records show evidence of the training employees undergo before executing assigned tasks.
Moreover, they enable the management to have an idea of:
- Training gaps
- Training that is past due
- Qualification needs
- Specific requirements for the department
- Recurrent issues with competence
- Efficiency of the training programs
What Should be Included in a Training Record?
The training record must have sufficient information to indicate what training was received and who attended it.Typically, the training record should include the following:
- Name or ID of the employee
- Name of the department
- Job designation or title
- Topic of the training
- SOP number or any related document number
- SOP revision number
- Date of the training
- Name of the trainer
- Method of training
- Assessment results, if required
- Confirmation by the employee in writing
- Confirmation by the trainer in writing
- Qualification status
- Automatic retraining or expiry date in certain cases
It is especially important to include the document number and revision for controlled documents.
Personnel trained on SOP-001 Rev.03 cannot automatically claim to have been trained on SOP-001 Rev.04 because the training system must indicate which version was used.
Initial and Job-Specific Training
Employees need to go through training that is right for their position before they are able to work independently in GMP-related tasks.Initial training modules may include information on:
- Principles of Pharmaceutical GMP
- Quality policy
- Data integrity
- Documentation
- Health and hygiene
- Safety
- Department procedures
As an example, a QC analyst should have training about analytical methods, instruction for instruments, laboratory documentation, OOS investigations and data integrity; while training of a production operator will be entirely different and will include knowledge about equipment, processing instructions, cleaning, line clearance and documentation.
Hence, the training should depend on the job that the employee has rather than giving everyone the same content.
Training Matrix
One of the most efficient instruments when it comes to controlling the training of employees is the training matrix.It matches the employees or job roles to the trainings they are required to complete.
For example:
| Training | Production | QC | QA | Engineering |
| GMP | Required | Required | Required | Required |
| Documentation Practices | Required | Required | Required | Required |
| Manufacturing SOPs | Required | No | Review | No |
| Analytical Methods | No | Required | Review | No |
| Equipment Maintenance | Relevant | No | Review | Required |
| Data Integrity | Required | Required | Required | Required |
The matrix should be able to show the trainings that have been finished, are outstanding, are overdue or are not applicable.
A practical tip that is often omitted is the fact that the training matrix should be aligned with the responsibilities of the specific job rather than with departments. Even two people working in the same department may require different training.
Training on Updated SOPs
When an SOP or controlled procedure is updated, the assessment must take place to determine the need for retraining.The evaluation should address the following issues:
- What has been changed?
- Is the change in question able to influence the performance of the task?
- Is the change able to affect the quality of the products?
- Does it introduce any new risks?
- Should the employee be demonstrated how to conduct the task?
In case retraining is deemed to be necessary, the employee must go through it before starting to perform the activities which are governed by the updated procedure unless the transition process has been documented.
Measuring the Efficacy of Training
Being present at training is not the key to being competent.The efficacy of training can be measured by means of:
- The use of tests
- The performance of practical tasks
- The observation of performance of the job
- Oral tests
- Qualification exercises
- An inspection of abnormalities in future performance
- An evaluation carried out by the supervisor
For instance, if the operator has passed the written test on equipment SOP, this does not mean that he or she is capable of operating the equipment properly. In such cases, practical qualifications serve as a better proof of competence.
The level of training evaluation should be proportional
Electronic Training Records
In modern times, a lot of pharmaceutical companies have resorted to the usage of electronic Learning Management Systems (LMS) for training management.The benefits offered by such systems include:
- Automation of training assignments
- Notifications regarding training deadlines
- Electronic signatures
- Control of training documents
- Training history
- Generated reports
- Alerts on missed trainings
- Dashboards for departments
While an electronic system enjoys a lot of benefits, it still does not comply with the regulations.
Common Training Record Deficiencies
Below are some common deficiencies:- Training that is completed after task commencement
- Either employee or trainer signature missing
- Wrong version of standard operating procedures (SOP) recorded in the training records
- Training matrices not modified following transfer of employees to other positions
- Uncontrolled overdue training process
- No documented assessment of the effectiveness of crucial operations
- Inconsistencies between training records and actual job function of the employee
- Absence of temporary staff in training management system
- Poor management of electronic training records
Training Records During Regulatory Inspections
At the time of the inspections, the inspectors may look up training records and check if employees are properly trained for their jobs.An effective system allows the organization to show how:
- The employee is authorized to work.
- The employee has received training on proper procedures.
- The employee used a certain version of the procedures.
- The employee completed the training.
- The employee's competency was evaluated.
- The employee has received refresher training.
Best Practices for Training Record Management
In order to have an efficient pharmaceutical education system, one must:- Identify the trainers’ duties in accordance with their profession.
- Have a well-organized training matrix, which shows all the necessary details.
- Educate the personnel before they start performing any tasks on their own.
- Ensure that there is a connection between training and revisions done on controlled documents.
- Make an assessment of efficiency in case of key operations.
- Keep track of overdue training.
- Have accurate training records, which can be tracked back.
- Review all the necessary training information in a timely manner.
- Incorporate temporary workers into the training process where possible.
- Monitor the trends in training in order to pinpoint the most popular skill gaps.
A good training system does not only include the fact of receiving a signature, but it links job responsibilities, revisions of the SOP, training requirements, competency assessment and ongoing certification.
The best organizations also use training data proactively. For instance, if a company receives many reports of violations, inaccuracies in documentation, mistakes in environmental monitoring or equipment operation, this may indicate that training is not effective enough. In such case, just assigning another training section will not solve the problem. It is necessary to analyze whether the problem is a badly prepared procedure or a lack of practical training, supervision or competency.
The training record should provide an overview of the training experience showing that the necessary person received the adequate training on the given procedure at the necessary time and demonstrated the appropriate level of competency.
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