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 procedures/policies to CFR requirements. The agency expects companies to establish comprehensive procedures that detail how staff members will be trained but also complies with the QSR record keeping requirements.The requirement 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 members 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 of these regulations is that training must be documented. The FDA is very serious about training or 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 show that lack of or inadequate training or incomplete training records is common warning letter deficiencies. Some recent observations include:

How do I create and document an effective training program?

I know your company has tons of procedures and policies, how do you select which policies and procedures are required for each individual? Well, you can train everyone on everything, in a small company that may work out. However, as your company grows, this system will quickly become a nightmare. Training everyone, in the long run, will result in ineffective training since employees will train on processes that do not relate to their assigned responsibilities. I recommend that job-specific training requirements should be identified by:

This team should: