Description
Summary:
Describes a procedure for ensuring a timely and effective retrieval of products distributed in Europe if the need for product recall arises. Intended to assure that the recall is notified in a correct way to the appropriate Competent Authorities if required. Covers inital action, customer notification, physical return of products, completion and coumentation. Includes provisions for compliance with MDD 94/42/EEC.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
Product Recall Action Report ,Table of Contents, Advisory Notice, Table of Contents
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
Product Details
- Edition:
- 2.0
- Published:
- 08/01/2007
- Number of Pages:
- 5
- File Size:
- 1 file , 320 KB
