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.
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It states that companies must ensure that their personnel have 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 Gx P practices as they relate to the employee’s duties.
You may want to consider archiving versions which contain older training records so your spreadsheet to not get out of control.
As an alternative or in conjunction to the Matrix, you may choose to create individual training records should contain the following items (at minimum): Whether you use the Matrix or individual training records, you will have to show how you are measuring the effectiveness of your training.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.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.Maintaining Training records can become burdensome, don’t let them take over.