Standard Operation Procedures

Training

Standard Operation Procedures
100,00 EUR
app. 132.00USD
(Non-german customers)

119,00 EUR
(German customers incl. 19% tax)



FDA
EMA
What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
GMP Money Back Guarantee
Here's how it works: Download your copy of this document and if for any reason your aren't completely satisfied after two entire months just give us a call, and we'll personally guarantee you get a complete refund.

Description of the Standard Operation Procedures - Training

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.

Table of Content

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

Training
100,00 EUR
Additional 19% tax for customers from Germany
Customers who bought this item also bought:
Deviations (failure investigations, non-conformance)
85,00 EUR
20.35% also purchased this product.
Annual product review
90,00 EUR
16.81% also purchased this product.
Supplier audit program
85,00 EUR
12.39% also purchased this product.
Supplier certification program
85,00 EUR
10.62% also purchased this product.
Site master file (SMF) for drug products
245,00 EUR
8.85% also purchased this product.
Self-inspection program
85,00 EUR
8.85% also purchased this product.
PAI protocol for drug products
210,00 EUR
7.08% also purchased this product.
Computer system validation and maintenance checklist
190,00 EUR
6.19% also purchased this product.
Hosting Regulatory Inspections
185,00 EUR
4.42% also purchased this product.
Testing Agreement for Medical devices
200,00 EUR
0.88% also purchased this product.
Product Recall
120,00 EUR

eCommerce Engine © 2006 xt:Commerce Shopsoftware