DOXPUB 12-0044-SOP

Summary:

Describes job skill training requirements for personnel in a device engineering function/department. Provides the necessary training to assure that all employees are able to perform their assigned functions and meet the training requirements of Good Manufacturing Practices. Applicable to all full-time Engineering Department employees, and at the discretion of management, this training SOP may also apply to temporary employees, contract employees, and consultants. Includes provisions for compliance with 21 CFR Parts 211.25 and 820.25.

Included Sections:

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

Included Attachments/Appendices:

Engineering Department Training Checklist

About This Document:

This is not a generic template, it's a 6-page procedure that was actually created and used in the Device Engineering 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:

• Engineering Managers
• Quality Assurance Managers
• Engineering Development & Manufacturing Personnel