The purpose of a Training SOP is to provide the facility and financial support where necessary for Site’s personnel to acquire the skills, knowledge and qualifications to perform effectively the duties and tasks for which they are employed.
This SOP should be in compliance with FDA 21 CFR Part 210 & 211 and the EU Directive for GMP’s.
This procedure covers the training skills level required of Site’s personnel (including temporary personnel) who perform functions that call for skills (i.e. GMP, etc.) where product quality and the quality system itself could be adversely affected by a lack of such skills.
Following attachments should be considered in a Training SOP:
- On-the-Job training form
- Training needs analysis form
- Course evaluation form
- Attendance register
- Request to attend training course form