| Title: GMP Training System | |||||
| Guidance Number: 81 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
GMP Training System
Introduction
This document discusses considerations for site GMP Training systems including training on regulations, GMP concepts, GMP tasks and knowledge necessary to perform those tasks.
GMP sites must comply with GMP requirements for training by defining the knowledge, skills and attributes colleagues must have to competently perform GMP tasks and other activities. This may be accomplished through education, training, experience or a combination thereof.
Introduction to the GMP Training System should be part of any colleague’s orientation to the site and should be the structure upon which all the GMP training needs of the colleague are met. This document will cover the various aspects of the system including job function curriculum, training record system, GMP orientation, SOP training, GMP concept training, structured on-the-job training, and training effectiveness assessments.
Scope
This document applies to all colleagues including temporary and part-time, performing job functions potentially impacting medicinal product integrity at production sites, laboratory sites, and logistics centers.
Recommendations and Rationale
Training System
Procedures and practices for managing and administrating GMP training including, but not limited to, planning, designing, executing, recording, and tracking training.
Components
Job Function Curriculum (JFC) – A list of all training (including SOPs, OJT and other topics) that must be completed and kept current for each person in that job function. Each of the items on the JFC are required to be completed as specified, unless there is a documented exemption for an item based on a combination of their previous education, training or experience. The JFC must include achievable targets that, once completed, allow the person to work on a GMP task without direct supervision
On-the-Job Training (OJT)– the one-to-one process of providing and mastering knowledge and skills to perform a specific task within a job.
Training should include specific criteria to be met to show that competence has been achieved in the task.
Training Record System – process for creating, filing, retrieving, and archiving training records that tracks and reports the status of completed and required trainings. Training records or reports must be readily available to substantiate that all employees performing GMP Related functions have completed the training requirements.
Training Effectiveness Assessment
Training Evaluation – instrument or methodology to gather feedback to improve the training process.
- Level I-Survey questionnaire that measures training effectiveness relative to satisfaction
Learning Assessment – instrument or methodology to assess how well the participants have met the defined learning objectives and or links to business results.
- Level II-measure trainee recall via written, verbal, computer based assessments, case studies, simulations or demonstrations
- Level III-measures trainee performance via direct observation, feedback from others, performance attributes or parameters
- Level IV-measures impact of training on business performance by evaluating business results, metrics or data.
GMP Orientation – training designed to provide new employees to a specific area the fundamental knowledge necessary to work in this area. For example, regulations, industry history, health and hygiene, documentation practices, GMP values and other site specific information.
GMP Concept Training – training designed to refresh colleague’s understanding and application of cGMPs. The courses should be designed to promote learning and improve colleague’s focus on cGMPs, regardless of their specific job function.
Standard Operating Procedure (SOP) Training – training designed for all employees impacted by new or revised SOP’s. This training must be completed prior to the effective date of the SOP therefore ensuring that the employee has been completely versed on all changes affecting their specific job function. Training should ensure that all employees understand the changes to their job function and the timing to which these changes are effective
Communication of Training – The site should notify effected employees of training far enough in advance for an employee to attend and also provide make up session(s) or alternative approach for those unable to attend.
Implementation Model for GMP Training System
Implementation – The implementation phase should include the following steps:
- An assessment of the job functions that have direct or indirect GMP impact,
- Determination of the knowledge and skill requirements to do tasks associated with the job, and
- Assessment of the risk to quality and business if those tasks are not completed competently.
- An SOP describing the training system,
- Authorization of training materials by the site Quality and Production leadership as appropriate.
- It may take time to build the system to its final state, so a planned, prioritized and documented phased approach to full implementation is recommended.
Measures and Monitoring –The system should be monitored on a continuous basis to ensure that all training requirements are being met. This process may include:
- A regular review of individuals’ JFC to determine if all training is up to date. This will ensure that all colleagues are adequately trained to perform their job functions according to the current procedures in place.
- A review of training records to ensure that all colleagues attend the required GMP Concept training sessions. A similar monitoring system can be employed for procedural type training, such as SOPs and Batch Records. This ensures that each colleague is fully trained on all necessary information needed to perform their job function. The review of the records can be performed manually for a paper based system or by creating and running a report in Electronic Learning Management System.
Continuous improvement –As with any system, monitoring for gaps and improvements means assessing whether training is effective, appropriate and adequate. The GMP Training System is an evolving system that should be structured based on the current working environment and the needs of business and colleagues.
- Training topics and focus should be relative to the activities occurring at the site. For examples, GMP Concept Training topics should be chosen so that they are pertinent to site and area needs. Department management should be involved, so that they can ensure that training topics are pertinent to colleague’s job functions, preventing deviation occurrences, past site regulatory observations or to address continual problems that occur in the area/site.
- The use of part time trainers should also continue to evolve. These colleagues should be representative of the types of training that is occurring at the site to ensure that their expertise is being utilized properly.
- Training materials such as job function curriculums and OJT materials need to be continually assessed for accuracy and updated to ensure they meet the current approved requirements at the site.
Defining and Determining Training Method
Communication – to provide general and/or basic knowledge of a GMP topic, issue or document that is useful for the audience but site leadership has determined is not critical to perform the current job function. This may include general revisions to SOPs such as grammatical errors.
Knowledge – information the audience needs to know as they routinely perform or oversee some or all of the tasks or activities described in the SOP.
Skill/Performance – the audience is directly involved in performing an activity or fulfilling the responsibility defined in the SOP and there are performance expectations of how well they can perform the task.
Training includes a witnessed and documented activity that a colleague can perform the functions relating to a particular activity/skill (as defined in an SOP) that they have direct responsibility for performing.
Training Method Decision Model (see appendix #2) to decide what type of training should be implemented, you should consider the audience and their job function as it relates to the subject. If the training information is general and will not directly change the colleague’s job performance, then communication may be adequate. This will inform colleagues of the information but not require any assessment of the training effectiveness. On the other hand, if the information, such as changes to an SOP, will directly impact the colleagues job performance, then knowledge or skill training may be required to ensure that colleagues understand and can apply this new information as well as perform the task as per the requirements.
Defining and Developing Trainers
Identifying Trainers – trainers should be identified based on their education, training and experience relative to the subject and demonstrated competence in: Assessing and defining training objectives
Effectively performing the appropriate training methodology for the audience and application Fully understanding the training content and relevant theory.
Selecting and using the appropriate training effectiveness assessment for the audience and application
Transferring instruction, knowledge and/or skills to others.
- Colleagues who are identified to be trainers should demonstrate a willingness and eagerness to perform this job function.
- Training for trainers should be provided for all trainers regardless of whether it is a primary or secondary job function. This training can include topics such as: presentation skills, body language, effective feedback, and developing PowerPoint presentations and assessments as well as other subjects that will enhance the trainer’s skills and effectiveness.
Roles and Responsibilities – (see appendix #1) the overall role and responsibility of the trainer will depend upon their job function and the personnel structure at the facility. Colleagues may be full time or part time trainers, therefore their responsibilities for training may be shared among others in their department or in assisting departments. In general, a site can separately define a Training System Owner, a full time trainer, and/or a part time trainer/department trainer/Subject Matter Expert (SME).
GMP Training System Owner – designated individual responsible for overseeing the effective, efficient and compliant implementation of the site GMP Training System.
Full time trainer – a person having the education, training and experience, relative to the training topic, and demonstrated competence. These trainers may perform communication, knowledge and/or skills based training. Typically these individuals will be responsible for developing training materials including presentation materials and training effectiveness assessments. These individual may also be responsible for the Training Records System.
Part Time Trainer – a person having the education, training and experience, relative to the training topic, and demonstrated competence. These trainers may perform communication, knowledge and/or skills based training. These individuals may also be referred to as department trainers, SMEs, occasional trainers, etc. These colleagues typically perform training as one part of their overall job function.
Continuous improvement – Training and trainers will continue to evolve as the regulatory industry evolves. Trainers should ensure that the training they are developing/presenting/coordinating is relative to the sites needs and the current regulatory environment. The use of part time trainers (SMEs, department trainers) should also evolve with the needs of the facility and training topics. These colleagues should be representative of the types of training that is occurring at the site to ensure that their expertise is being utilized properly.
Model Training System(see appendix #3)
The attached document is one model for how a GMP Training System can be established. This system includes each of the components of GMP Orientation, JFCs, SOP training, GMP Concept Training, OJT, training records and training effectiveness assessments. This model helps to visualize how these components all link together to form one system.
It also establishes what type of GMP training is necessary for new colleagues, transferred colleagues, and colleagues with new job functions.
GMP Concept Training has a dotted line in this flowchart. That is because this type of training can occur at any point during the employees’ employment at the facility. It may not be a requirement for employees to attend GMP Concept Training prior to performing GMP tasks, so long as they have fulfilled all of the requirements in their JFC.