This is a collection of Provision, Procedure, and Forms related to training in a form consistent with the FDA QSR.
As manufacturing processes and procedure become more diverse, training are now strictly required.

List of Forms
The following forms are included with your purchase.
・MD-QMS-F301 Training Annual Plan and Report
・MD-QMS-F302 Training Plan and Report
・MD-QMS-F303 Individual Training Course History
・MD-QMS-F304 List of Ability
・MD-QMS-F305 Departmental Competence Table (Skill Map)
・MD-QMS-F306 List of Training Attendees
・MD-QMS-F307 Education and Training Staff Qualification Form
・MD-QMS-F308 Training curriculum
・MD-QMS-K3 Training Provision
・MD-QMS-S301 Training Procedure

Table of Contents

Provision

1 Purpose
2 Scope
3 Definition of Terms
4 Training Purpose
5 Training Manager
6 Training staff
6.1 Certification
6.2 Ability
7 Training
8 Training planning and implementation
9 Training implementation records and storage
10 Reference
11 APPENDICES

Procedure

1 Purpose
2 Scope
3 Definition of Terms
4 Roles and Responsibilities
5 Certification of Training personnel
6 Training implementation procedures
6.1 Creation of Competency Chart
6.2 Curriculum development
6.3 Prepare annual training plan and report (at time of planning)
6.4 Training
6.5 Create training records at
6.6 Assessment of competence
6.7 Prepare annual training plans and reports (at the time of reporting)
6.8 Evaluation of training results
6.9 Record keeping
7 Form
8 Reference
9 APPENDICES