Summary:

Describes a quality system training program. Identifies the necessary training to assure that personnel are made aware of how the improper performance of their specific jobs may result in production and/or release of defective product. Intended to assure that personnel are made aware of how the improper performance of their specific jobs may result in the delivery of service that does not meet the company's quality standard, and that personnel have an understanding of the current drug and device GMPs, ISO and Medical Device Directives (MDD) regulations as they relate to their job functions.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Training Notification Form, Training Topic Guidelines

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Quality Assurance operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

Use it as a starting point for your own documentation project

Compare the quality of your documents against your industry peers

Learn what other companies in your industry are actually doing

Who Will Benefit:

Quality Assurance Managers

Manufacturing Managers

Quality Control Personnel