Training and the FDA – What do They Require?

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:

• 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 C.F.R. § 820.25(b). https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm398309.htm
• At the time of the inspection, your firm did not have training records demonstrating that the operators were adequately trained to perform the activities and test methods used during production. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm399519.htm
• 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.

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:

• Human Resources to identify general corporate policies and procedures
• Area Managers and Supervisors to identify job specific procedures and work instructions
• Quality Assurance to identify appropriate Quality System policies and procedures

This team should:

• Analyze the companies training needs:
  • Identify personnel requirements and
  • Identify staff members which need to be trained
  • 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

Establishing a team comprised of HR, Area Managers/Supervisors and QA ensures that all appropriate policies and procedures are identified for each employee by job title or individually. Once training requirements have been identified it is now time for…..yes, I have to say it.The Training MatrixThe dreaded spreadsheet’ 3You know what I mean, the Training Matrix – that “living” maze of columns, dates, & color coding. That monster spreadsheet that grows, grows and gets more and 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 uniformed for every employee with the same job titles. The real function of the Training Matrix is to:

1. Identify individual/job-related training requirements
2. To track pending and completed training per individual and/or departments, thus ensuring appropriate training has been completed.
3. To be able to quickly provide an outside auditor/investigator with the company’s current training records.

The Matrix should identify Policies/Procedures; Versions; Training completed or pending; Training Date; Method of training (ie. classroom, webinar, 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 that contain older training records so your spreadsheet to not get out of control. As an alternative or in conjunction with the Matrix, you may choose to create individual training records should contain the following items (at minimum):

• Employees Name & Job Title
• Training Topic
• Date of Training
• Training method
• Trainer

Whether you use the Matrix or individual training records, you will have to show how you are measuring the effectiveness of your training. To show effectiveness, you may want to create a training survey for participants to complete to help identify courses that are relevant and effective for specific jobs. Surveys provide the company an opportunity to evaluate the trainer, and to determine if the class meets the companies’ training needs. Some questions that may be included on a survey are:

• Did this course cover job related responsibilities?

• Will the information learned in this course assist you with your assigned tasks?

• Did you understand the information and/or regulations discussed in this class?
• Will you use any of the information discussed in this course to improve compliance and/or job-specific task performance?

To further show your company’s desire to ensure training appropriateness and effectiveness, including a section for Manager/Supervisor comments regarding noticeable individual/group compliance and/or performance improvements related to the information provided during training. If you are concerned with your surveys adding 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 are one of those fortunate companies who invested in regulatory-compliance-software which will facilitate this entire process considerably. Compliance-software allows Managers/supervisors to concentrate on other productivity and compliance-related issues. Maintaining Training records can become burdensome, don’t let them take over. If you have any questions, or want assistance with your compliance needs, contact me or call me directly at IPRF, LLC 619-634-9837 for RA/QA Compliance Consulting or [email protected] if you need assistance with international product registration.