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Facility Design Manufacturing Quality Audit Training Due Diligence FDA / CMC

   

Employee training is a critical compliance requirement for cGMPs, QSRs, GTPs and GLPs.  The cGMP regulations require:

"§ 211.25 Personnel qualifications.

(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.  Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions.  Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them."

The other regulations have similar requirements.

We provide our clients with on-site training services, specifically designed for their organizations.  We also assist in the development of a documented training system that will meet regulatory requirements:

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Annual training on the regulations.

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We provide required training on the specific 21 CFR regulations that are appropriate for each client organization.

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Generally this training includes a PowerPoint presentation introducing the topic of the FDA regulation process and presentation sections that are specific to the regulations necessary for the client's operations.  Examples of FDA Warning Letters and other regulatory actions are discussed to illustrate the need for compliance.

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A electronic training manual is provided with copies of the slides, Warning Letters and full copies of each 21 CFR regulation covered in the presentation.

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The client may videotape the training session to use as part of his new employee orientation process.

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Job specific training.

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The regulations require that each employee have documented training on the written procedures (SOPs and other documents) that are related to that employee's job function.  This training must be completed and documented within the employee's training file, before he performs any action, process or procedure described under the SOP.

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We assist organizations in setting up their job specific training program and its documentation.  We also provide training for the "Trainers."  It is most appropriate for job specific SOP training to be conducted by supervisors for each job function in conjunction with oversight by the quality organization.

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Except for SOP revisions associated with minor typographical corrections, the statement "read and understood" is not appropriate or sufficient to document an employee's training on a specific procedure.  Inspectors particularly question employee training files that list training on several SOPs on the same calendar day.  These and similar problems should be addressed by a suitable and compliant job specific training program.

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Other training.

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Other (non-FDA) training is part of the orientation program most organizations conduct for their new employees.  Examples include safety training, sexual harassment training, personal and corporate responsibility training, employee benefits training, etc.  More senior employees may receive leadership training, motivational training, etc.  These training programs are generally the responsibility of a human resources function.

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We strongly suggest that all training associated with FDA compliance be kept strictly separate from other employee training programs.  Compliance and regulatory associated training and its documentation should be the responsibility of the Quality organization.

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