Training Requirements

Training Requirements. The Manufacturer shall establish and maintain a training program that ensures all personnel involved in the manufacture, testing, storage, and distribution of products are adequately trained and qualified to perform their assigned duties. Training shall include, at a minimum: (a) initial training prior to performing any job function, including cGMP requirements, SOPs applicable to the employee's role, and safety procedures; (b) periodic retraining at defined intervals, not to exceed two (2) years, to ensure continued competency; (c) training on all revised or new SOPs prior to their effective date; (d) job-specific technical training for specialized operations such as aseptic processing, analytical testing, and equipment operation; and (e) documentation of all training activities, including the training date, subject matter, trainer credentials, and trainee assessment results. Training records shall be maintained in individual training files for each employee and shall be available for review during audits. Personnel shall not perform any task for which they have not been trained and deemed competent.