Your Account |

Show all documents

Standard Operating Procedure

Checklists Master Plans

Pre-Approval-Inspection

GMP Guide

Standard Operation Procedure

FDA

Process Validation

Bookmark this site:

Training
Standard Operating Procedure

Description:
Training is considered an essential tool for human resources management and for ensuring the workforce is appropriately qualified to perform its duties. This Standard Operating Procedure (SOP) covers the training skills level required of site personnel (including temporary personnel) who perform skilled functions (i.e. GMP, etc.) where product quality and the quality system itself could be adversely affected by a lack of appropriate skills.

This Standard Operating Procedure (SOP) was written to incorporate all comprehensive training activities into one system to ensure that all personnel acquire the skills, knowledge and qualifications needed to effectively carry out their duties and tasks. This SOP (Standard Operating Procedure) can be applied to all pharmaceutical GMP-regulated areas such as drug products, active pharmaceutical ingredients, excipients, vaccines and medical devices. This 15-page SOP includes 5 attachments: an on-the-job training form, a training needs analysis form, a course evaluation form, an attendance register form and a training course attendance request form.

Download sample page



	Price:	89.– EUR * (appr. 115.- USD)

* additional 19% tax for customers from germany / no shipping costs will be charged



	Delivery item:
		Open Word Document* You will be able to enter your data into the Word document. Please note: We do not deliver hard copies.



	Further details of this Standard Operation Procedure: Table of Content of this Standard Operating Procedure: 1. Regulatory Basis, Reference Documents 2. Purpose 3. Scope 4. Responsibilities and Accountabilities 4.1 Management Team and Supervisory Staff 4.2 Quality Manager 4.3 Human Resources Officer 4.4 Technical Director 5. Training Procedure 5.1 Orientation Program (induction) 5.2 On-the-Job Training 5.3 Needs Analysis 5.3.1 GMP Training 5.3.2 Ad hoc GMP Training 5.3.3 Environment Health and Safety Training 5.4 Training schedule 5.5 Registering of names 5.6 Training execution 5.7 Training follow-up 5.8 Non-Attendance of courses 5.8 Training records 6. Definitions 7. Distribution 8. Attachments Appendix 1: On-the-Job Training Form Appendix 2: Training needs analysis form Appendix 3: Course evaluation form Appendix 4: Attendance register Appendix 5: Request to attend training course form

Customers who bought this item also bought:

Change control system

Annual product review

Supplier certification program

Deviations (failure investigations, non-conformance)

Product Recall


	© GMP ONLINE CONSULTANCY - Impressum - Imprint

Training Standard Operating Procedure

Training
Standard Operating Procedure