Exmoor advised in its response that professional auditor training will be provided and that subsequent in-house training will be conducted and documented for key staff with auditing responsibilities. Furthermore, training needs will not only be assessed during appraisal and counseling sessions, but also during Quality Management Review Meetings, external audits, internal audits and corrective actions. We understand that documentation will utilize a computer and Excel spreadsheets within the Production Department. It will be necessary for FDA to review the applicable procedures, such as the internal audit and corrective action procedures, and an example of the Excel printout for documenting training once they are developed.
