The FDA requires that drug and device manufacturers train their personnel. The agency puts the burden on firms to establish comprehensive procedures that not only specifies how personnel will be trained, but also outlines the record keeping requirements for the program. During an FDA inspection, the investigator will examine the firm’s records to ensure that the firm is following its procedures and the program is effective. The investigator also will examine complaint files and will try to determine if the cause of a complaint can be traced back to inadequate training. Complaint management software can help reduce the risk of complaint handling issues. The requirement for training for drug firms in contained in 21 CFR 211.25 The regulation requires that drug firms ensure that their personnel have the education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. The drug firm needs to provide training in the particular operations that the employee performs and in current good manufacturing practices as they relate to the employee's functions.
The requirement for training for medical device firms is contained in 21 CFR 820.25(b) Device firms need to establish procedures for identifying training needs and ensuring that the all personnel are adequately trained to perform their assigned responsibilities. Part of the training program should be to make all employees, including those involved with verification and validation activities, aware of the defects that could result from the improper performance of their jobs. The regulations also require that the training be documented.
What will investigators look for during FDA inspections? During an FDA inspection, the investigator will check the training records to see that a firm’s training program is adequate. A search of FDA’s website reveals that a lack of, or inadequate training or incomplete training records are common warning letter deficiencies.
Sample citations include:
- Failure to establish and maintain adequate procedures for identifying training needs
- Failure to ensure that each person has the education, training and experience to perform their assigned functions
- Failure to include specific information in the training; and
- Failure to train the manager of operations whose duties include implementing corrective and preventive action (CAPA), nonconfomances, and complaint handling on the quality system regulation
- Failure to document that all personnel are trained to adequately perform their assigned responsibilities
How can firms create an effective training program?
Companies need to appoint a training coordinator who should meet with each department head to:
- Analyze the requirements;
- Determine which personnel need to be trained on which task;
- Describe the body of knowledge that goes along with that task;
- Decide whether classroom training, on-line training, or on the job training is most appropriate; and
- Take charge of maintaining the training records.
For classroom training, the training coordinator should locate qualified instructors who have the required background and experience in the subject matter. Keeping resumes of all trainers on file permanently satisfies FDA requirements for record retention. Companies will return to these records as new training needs arise.
When firms establish their standard operating procedures for documenting training, they should include such elements as:
- The reason for the training;
- Who conducted the training;
- How the training was conducted;
- When it occurred;
- Who attended; and
- How effectiveness was measured.
To create effective and FDA-compliant training programs, firms need to adopt a culture of learning. Firms on a continuing basis need to devote resources to perform a needs assessment, implement a training program, evaluate its effectiveness and make sure all of the records are complete and up to date. A good training program is a resource intensive endeavor. However, when firms examine their return on investment, they will realize that it is worthwhile, as it is likely to result in a loyal and professional work force that produces safe and effective products.
Nancy Singer is the president of Compliance-Alliance, LLC
Previously she was AdvaMed’s Special Counsel and founder and former executive director of AdvaMed’s Medical Technology Learning Institute.