This procedure covers the training program and skills levels required of personnel (including temporary personnel) performing 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.

Regulatory basis, reference documents

• 21 CFR Part 211.25 (a)
• EU Directive for GMP’s

Table of Content (just Headers):

1          Purpose

2          Objective

3          Regulatory basis, reference documents

3.1       Company Management

3.2       Quality Management Representative / Quality Assurance / (Recall coordinator)

3.3       Management Team and Supervisory Staff

3.4       Human Resources

3.5       Department Manager

4          Related documents

5          Definitions

6          Procedure

6.1       General

6.2       On-the-Job Training

6.3       Training Need Analysis

6.3.1    GMP Training

6.3.2    Ad hoc GMP Training

6.3.3    Environment Health and Safety Training

6.4       Training schedule

6.5       Registering of names

6.6       Training execution

6.7       Training follow-up

6.8       Non-Attendance of courses

6.9       Training records

6          Attachments

6.1       Attachment 1: On-the-Job training form

6.2       Attachment 2: Training needs analysis form

6.3       Attachment 3: Course evaluation form

6.4       Attachment 4: Attendance register

6.5       Attachment 5: Request to attend training course form        11

7          SOP distribution        11

8          Health, safety and environmental considerations     11

Size and Format:

Microsoft Office

Word File

17 pages procedure

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