DOXPUB 12-0043-SOP

Summary:

Describes job skill training requirements for employees in the antibody development department. Provides the necessary training to assure that all employees are able to perform their assigned functions and the training requirements of Good Manufacturing Practices. Applicable to all Antibody development department employees including full-time and temporary employees, contract employees, and consultants.

Included Sections:

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

Included Attachments/Appendices:

Antibody Development Department Training Checklist

About This Document:

This is not a generic template, it's a 1-page procedure that was actually created and used in the Laboratory R&D 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:

• Process Development Personnel
• Method Development Personnel
• Quality Control Personnel