Patient safety is the result of controlling product quality in the pharmaceutical industry. The quality of each product is affected not only by advanced equipment, validated processes and strict regulatory controls but also by one consistent factor that drives quality outcomes for all pharma operations: Training Management.
Human error is one of the most significant causes of deviations, batch failures and compliance issues within the pharmaceutical industry. Effective Training Management also provides the personnel who actually perform the work with the information to understand procedures, be able to follow the standards and execute the processes to perform the qualified tasks. When a Training System lacks effectiveness, Quality Issues become more common and more likely to repeat.
Personnel Training is emphasized as a direct requirement of Good Manufacturing Practice by numerous regulatory entities including FDA (U.S.); WHO (Global); and EMA (Europe).
This article discusses the impact of Training Management as it relates to Quality Issues and presents best practices to create a robust Training Management System that complies with all applicable regulations.
Types of Training Managed Through Training Management Systems Include:
- Induction training for new employees
- Job-specific technical skills training
- Training on Standard Operating Procedures (SOPs)
- Training on Good Manufacturing Practices (GMPs) and other regulatory compliance issues
- Training used to refresh employees’ skills and periodically (re)qualifying them to do their jobs properly.
Developing a well-designed training management system is essential for ensuring that all employees have the necessary skills to perform their duties as assigned without negatively impacting the quality of the products manufactured or packaged for sale.
Proper implementation of a training management system will help to reduce:
- Human errors
- Compliance with SOPs
- Consistency of processes
- Compliance to regulatory requirements
- Quality Culture
When the employees understand their responsibilities and have received proper training on how to perform them effectively, they are far more confident, efficient and capable of identifying potential problems and preventing them from occurring as compared to employees who have received only minimal or no training.
Examples of these types of mistakes are as follows:
- Incorrect machine settings,
- Improper use of cleaning procedures
- Failure to properly follow the steps of a SOP
Once an error is made it is likely that the result will be classified as a deviation and require investigation and/or corrective action.
If personnel are poorly trained then it can lead to errors in documentation, whether that be as a result of:
- Incomplete or incorrect records,
- Missing data entries
- Data integrity issues
These types of errors can create significant concerns during regulatory inspections.
If the proper training is not provided or personnel does not retain that knowledge then they will likely perform their work differently than intended due to:
- Lack of understanding or
- Misinterpretation of the instruction or
- Over confidence and/or cutting corners.
Any type of non-compliance with an SOP affects the product’s quality and regulatory compliance.
- Improper gowning technique or
- Poor hand hygiene or
- Incorrect handling of materials
Contamination is especially important in sterile manufacturing environments.
5. Repeated CAPA Issues
If personnel have not received proper training and/or did not retain that training, it is likely that they will repeatedly make the same mistake(s) even after there has been a corrective action taken.
This will indicate that the root cause of the error was the individual’s lack of competency and that this issue has not been effectively addressed.
This includes:
- Defining the job responsibilities
- Identifying the competencies needed for each position
- Identifying any gaps in training
Training should be specific to each position and not a one size fits all approach.
Training programs should have:
- Clear objectives
- Defined training content
- Standardized materials
- Trained instructors
A structured training program will ensure the same level of training for every employee.
Employees should be trained on:
- Relevant SOPs to their job positions
- Any changes to or new SOPs
- How to properly implement the SOPs into their daily tasks
Training should not only consist of reading the SOPs but also understanding the SOPs and how to apply the SOPs.
Hands on training will provide the employees the opportunity to:
- Perform tasks in a real world environment
- Operate equipment correctly
- Learn proper methods for performing tasks
Practical training will improve the employees' skill level and decrease the number of errors they make on the job.
Training can be measured with the following assessment tools:
- Written Assessment
- Demonstration
- On-Site Assessment
The Verification Process provides the ability to establish that employees are able to perform their tasks in a competent manner.
Ongoing training will ensure:
- Retention of Knowledge
- Awareness of Updates to Existing Procedures
- Continuous Improvement of Skills
Requalifying of Staff is particularly important for critical functions and operations.
The records should include:
- Date(s) of Training
- Topics of Training
- Trainer Name(s)
- Assessment Results
Regulatory agencies frequently review records of training to ensure compliance.
Examples of digital systems include:
- Learning management systems (LMS)
- Electronic quality management systems (EQMS)
Digital training systems allow for:
- Tracking of training completion
- Automation of training reminder notifications
- Accuracy of records of training
Digital systems increase efficiency of training and decrease the administrative burden on organizations.
The role of executive management in training includes:
- Allocation of Resources
- Monitoring of Compliance with Training
- Review of Training Metrics
- Fostering a Culture of Learning
Commitment to leadership is essential for a successful training program.
Regulatory bodies expect:
A culture of quality through training creates a workforce that:
Training Management has a direct and significant impact on quality problems in the manufacture of pharmaceuticals. When there is poor training, it leads to errors, deviations and compliance issues. Conversely, effective training will improve both performance and the consistency and quality of products.
Pharmaceutical manufacturers can reduce quality issues through the use of structured training programs, focusing on the development of competencies within the framework of regulatory requirements and working to continually evaluate the effectiveness of all training.
Employee in high-regulated industries with the goal of a safe environment for patients are the key to providing quality and compliance.
Personnel Training is emphasized as a direct requirement of Good Manufacturing Practice by numerous regulatory entities including FDA (U.S.); WHO (Global); and EMA (Europe).
This article discusses the impact of Training Management as it relates to Quality Issues and presents best practices to create a robust Training Management System that complies with all applicable regulations.
What is Training Management in Pharmaceuticals?
Training Management refers to the systematic method of planning, implementing, tracking and evaluating employee training programs in the pharmaceutical industry.Types of Training Managed Through Training Management Systems Include:
- Induction training for new employees
- Job-specific technical skills training
- Training on Standard Operating Procedures (SOPs)
- Training on Good Manufacturing Practices (GMPs) and other regulatory compliance issues
- Training used to refresh employees’ skills and periodically (re)qualifying them to do their jobs properly.
Developing a well-designed training management system is essential for ensuring that all employees have the necessary skills to perform their duties as assigned without negatively impacting the quality of the products manufactured or packaged for sale.
Why Training Management is Critical for Quality
Pharmaceutical production is a very complex and precisely controlled process; even the smallest mistake in any of the numerous steps can lead to serious consequences, including product contamination, the rejection of lots and failure to comply with regulatory agencies.Proper implementation of a training management system will help to reduce:
- Human errors
- Compliance with SOPs
- Consistency of processes
- Compliance to regulatory requirements
- Quality Culture
When the employees understand their responsibilities and have received proper training on how to perform them effectively, they are far more confident, efficient and capable of identifying potential problems and preventing them from occurring as compared to employees who have received only minimal or no training.
Common Quality Issues Linked to Poor Training
The root cause of many quality issues in the pharmaceutical Industry can be linked to inadequate or ineffective training in the workplace.1. Deviations and Errors
Personnel who have not been adequately trained will be unable (or poorly trained) to understand the procedures that are in place for performing their work, which can lead them to make mistakes with operations.Examples of these types of mistakes are as follows:
- Incorrect machine settings,
- Improper use of cleaning procedures
- Failure to properly follow the steps of a SOP
Once an error is made it is likely that the result will be classified as a deviation and require investigation and/or corrective action.
2. Documentation Errors
Documentation is a critical part of any pharmaceutical operation.If personnel are poorly trained then it can lead to errors in documentation, whether that be as a result of:
- Incomplete or incorrect records,
- Missing data entries
- Data integrity issues
These types of errors can create significant concerns during regulatory inspections.
3. Non-Compliance with SOPs
Properly trained personnel, will be competent in understanding and following the company’s SOPs.If the proper training is not provided or personnel does not retain that knowledge then they will likely perform their work differently than intended due to:
- Lack of understanding or
- Misinterpretation of the instruction or
- Over confidence and/or cutting corners.
Any type of non-compliance with an SOP affects the product’s quality and regulatory compliance.
4. Contamination Risks
Personnel who are not properly trained in regard to hygiene, gowning and clean room behaviour will have higher chances of introducing contaminants into sterile manufactured products due to:- Improper gowning technique or
- Poor hand hygiene or
- Incorrect handling of materials
Contamination is especially important in sterile manufacturing environments.
5. Repeated CAPA Issues
If personnel have not received proper training and/or did not retain that training, it is likely that they will repeatedly make the same mistake(s) even after there has been a corrective action taken.
This will indicate that the root cause of the error was the individual’s lack of competency and that this issue has not been effectively addressed.
Key Elements of Effective Training Management
In order to prevent quality related problems, pharmaceutical companies need a solid training management system.1. Identify Training Needs
The first step is to identify the training needs for each position.This includes:
- Defining the job responsibilities
- Identifying the competencies needed for each position
- Identifying any gaps in training
Training should be specific to each position and not a one size fits all approach.
2. Structured Training Programs
Training programs should be structured and have documentation.Training programs should have:
- Clear objectives
- Defined training content
- Standardized materials
- Trained instructors
A structured training program will ensure the same level of training for every employee.
3. SOP Based Training
All critical pharmaceutical operations are governed by standard operating procedures (SOP's).Employees should be trained on:
- Relevant SOPs to their job positions
- Any changes to or new SOPs
- How to properly implement the SOPs into their daily tasks
Training should not only consist of reading the SOPs but also understanding the SOPs and how to apply the SOPs.
4. Practical and Hands on Training
Theoretical knowledge alone is not enough.Hands on training will provide the employees the opportunity to:
- Perform tasks in a real world environment
- Operate equipment correctly
- Learn proper methods for performing tasks
Practical training will improve the employees' skill level and decrease the number of errors they make on the job.
5. Measurement of Effectiveness and Competency of Training
In order to measure the competency of trainees, the effectiveness of training must be measured.Training can be measured with the following assessment tools:
- Written Assessment
- Demonstration
- On-Site Assessment
The Verification Process provides the ability to establish that employees are able to perform their tasks in a competent manner.
6. Continuous Training and Requalifying of Staff
Training should not be viewed as being a single event.Ongoing training will ensure:
- Retention of Knowledge
- Awareness of Updates to Existing Procedures
- Continuous Improvement of Skills
Requalifying of Staff is particularly important for critical functions and operations.
7. Documentation and Record Keeping
It is imperative that organizations maintain accurate records of training for compliance purposes.The records should include:
- Date(s) of Training
- Topics of Training
- Trainer Name(s)
- Assessment Results
Regulatory agencies frequently review records of training to ensure compliance.
8. Digital Training Systems
Pharmaceutical manufacturers utilize digital systems in order to manage training.Examples of digital systems include:
- Learning management systems (LMS)
- Electronic quality management systems (EQMS)
Digital training systems allow for:
- Tracking of training completion
- Automation of training reminder notifications
- Accuracy of records of training
Digital systems increase efficiency of training and decrease the administrative burden on organizations.
9. Involvement of Executive Management
Executive management has a significant role in the effectiveness of training programs.The role of executive management in training includes:
- Allocation of Resources
- Monitoring of Compliance with Training
- Review of Training Metrics
- Fostering a Culture of Learning
Commitment to leadership is essential for a successful training program.
Regulatory Expectations for Training
Training is a critical component of Good Manufacturing Practices.Regulatory bodies expect:
- Training programs that are documented
- Demonstrated competency of employees
- Refresher training that is conducted on a regular basis
- Training that is job-related
Measuring the Effectiveness of Training
In order to measure the extent that training has assisted in improving quality, organizations should track KPIs including the following:- Decreased deviations
- Decreased human error
- Increased number of successful audits
- CAPA resolution success rates
- Employee competency scores
Building a Culture of Quality via Training
Training is not merely to provide compliance; rather, it is to build a culture of quality in an organization.A culture of quality through training creates a workforce that:
- Is aware of their duties
- Has respect for quality in their daily activities
- Minimizes the likelihood of making errors
- Encourages continuous improvement
Training Management has a direct and significant impact on quality problems in the manufacture of pharmaceuticals. When there is poor training, it leads to errors, deviations and compliance issues. Conversely, effective training will improve both performance and the consistency and quality of products.
Pharmaceutical manufacturers can reduce quality issues through the use of structured training programs, focusing on the development of competencies within the framework of regulatory requirements and working to continually evaluate the effectiveness of all training.
Employee in high-regulated industries with the goal of a safe environment for patients are the key to providing quality and compliance.
Frequently Asked Questions (FAQs) on Training Management
Q1. What is the function of training management for pharmaceuticals?
Answer: It is a system that plans, delivers and evaluates an employee’s training program.Q2. Why does quality depend upon training?
Answer: Training provides a foundation for reducing errors, assuring compliance to SOP’s and improving product consistency.Q3. Problems caused by inadequate training
Answer: Deviations, errors in documentation and contamination.Q4. How do you measure training effectiveness?
Answer: By means of a test, practical assessments and evaluating performance.Q5. Which guidelines require training?
Answer: The Good Manufacturing Practice regulations.Q6. What is SOP Training?
Answer: Training that involves the employee receiving training on the Standard Operating Procedures (SOPs) that pertain to that employee’s job.Q7. What is the frequency of training?
Answer: Training should be conducted on a consistent basis. New employees must be trained upon hiring and all employees should receive periodic training in the same manner.Q8. Will training help reduce CAPA's?
Answer: Yes, it can prevent the reoccurrence of the same problems by increasing competencies.
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