DOXPUB 09-0015-SOP PDF

Summary:

Describes the responsibilities and activities of the Material Review Board (MRB). Covers identifying the individuals who are on the Material Review Board, identifying what issues are brought before the Material Review Board, organizaing and preparing for MRB meetings, conducting and documenting the outcomes of MRB meetings, dissemination of MRB conclusions and corrective actions, and quality assurance monitoring.

Included Sections:

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

Included Attachments/Appendices:

Material Review Board (MRB) Request and Report Form, MRB Member Matrix

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Regulatory Affairs 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:

• Regulatory Affairs Managers
• Quality Assurance Managers
• Manufacturing Managers