The FDA requires medical device and drug manufacturers to train their employees. Training must occur for all types of regulated activities from internal quality management software procedures/policies to CFR requirements. The agency expects companies to establish comprehensive procedures that not only detail how the staff will be trained but also complies with the QSR record keeping requirements.
The requirements for training is defined in 21 CFR 211.25 for pharmaceuticals. It states that companies must ensure that their personnel has the education, training, and experience to perform their assigned duties. Pharmaceutical companies need to provide training in the tasks that the employees will perform and in GXP practices as they relate to the employee’s duties.
For medical device firms, training requirements are defined in 21 CFR 820.25(b). Device companies are required to establish procedures for identifying training needs and ensure that personnel is appropriately trained to perform their assigned tasks. Company training should ensure employees, including staff specifically involved with verification and validation activities, are made aware of defects issues that could result from the improper completion of their responsibilities.
The common thread for both regulations is that training must be documented! The FDA is very serious about training or the lack of training. Generally, FDA investigators will check training records to verify that a company’s training program is adequate. Take a moment to look at FDA’s website Warning Letters which shoe that lack of or inadequate training or incomplete training records are common warning letter deficiencies.
Some recent observations include:
- Failure to establish procedures for identifying training needs and ensure that all personnel is trained to adequately perform their assigned responsibilities as required by 21 CFR 820.25(b). Click here.
- At the time of the inspection, your firm did not have training, your firm did not have training records demonstrating that the operators were adequately trained to perform the activities and testing methods used during production. Click here.
- Failure to train production employees responsible for quality functions as required by 21 CFR 820.25(b). Your firm’s Training procedure, Document (dated 05/21/13) requires all employees to be trained “to perform the assigned responsibilities” and also requires the maintenance of training records. However, no records were provided to demonstrate that b(4) employees who performed design control activities had been trained to the Design Control procedure, Document. In fact, there were no training records at all for these three employees. Click here.
How do I create and document an effective training program?
I know your company has tons of procedures. How do you select which polices and procedures are required for each individual? You can train everyone on everything and in a small company that may work out but as the company grows this system will quickly become a nightmare. Training everyone is ineffective training since employees are trained on processes that may not relate to their assigned responsibilities.
We developed this infographic to guide you in creating and documenting an effective training program.
The Training Team
Establish a team comprised of HR, Area Managers/Supervisors, and QA to ensure that all appropriate policies and procedures are identified for each employee by job title or individually as the case may be.
Once training requirements have been identified, it’s now time for — Yes, I have to say it —
The Training Matrix
The dreaded spreadsheet (Ugh!). You know what I mean — the ‘living’ maze of color-coded columns of dates and other pertinent information — that monster spreadsheet that grows and grows and gets more complex until you’re ready to run screaming from your office! Unfortunately, this is a necessary evil. I suggest this document should be divided by job title to ensure that training is uniform for every employee with the same job titles.
The matrix should identify policies/procedures; versions; training completed or pending; training dates; and training methods, i.e., webinar, classroom or on-the-job. Since this is a ‘living’ document, it is recommended that you periodically review and update as needed. You may want to consider archiving versions which contain older training records so your spreadsheet does not go out of control.
As an alternative or in conjunction with the matrix, you may choose to create individual training records containing the following items:
- employee name and job title
- training topic
- training date
- training method
- trainer
The Training Survey
You need to show how you are measuring the effectiveness of training. To show effectiveness, you may want to create a Training Survey to help identify courses that are relevant and effective for specific jobs. Surveys provide an opportunity to evaluate the trainer and to determine if the courses meet the company’s training needs.
To further show the company’s desire to ensure training appropriateness, include a section for Manager/Supervisor comments regarding noticeable individual/group compliance and/or performance improvements related to the information provided during training.
If you’re concerned that surveys will add another layer of paper to your already overflowing stacks, especially if you maintain individual training records, consider adding a section to the individual training records for survey questions and manager comments.
If you’re fortunate, your company has invested in regulatory compliance software which will facilitate this entire process considerably. Compliance software allows managers to concentrate on other productivity and compliance-related issues. Maintaining training record can become a bear, don’t let them take over.
If you have any questions or want assistance with your compliance needs, contact me at www.360factors.com or call me directly at 512-539-2732 for RA/QA Compliance Consulting and if you need assistance with international product registration.
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