DOXPUB 13-0013-SOP PDF

Summary:

Describes a certification program to ensure the proper use of products labeled for Research Use Only and allow distribution prior to approval by FDA. Applies to specific products as determined by the Director of Regulatory Affairs. Includes references to immunocytochemistry kits sold in the United States but it can easily be adapted for other products and materials.

Included Sections:

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

Included Attachments/Appendices:

Certification Form Letter

About This Document:

This is not a generic template, it's a 3-page procedure that was actually created and used in the Sales & Marketing 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:

• Sales & Marketing Managers
• Regulatory Affairs Managers
• Executive Management