Contents

Interim Change Notice

Effective Date: 11/01
Point of Contact: Quality Engineer for Regulatory Programs

The Interim Change Notice is provided as a word file.

Instructions for completing the form are provided below.

SECTION A - Self-explanatory.

SECTION B - Include all actions that the document holder must take to update the procedure or instruction. Possible actions include: replacing pages of the document with pages which are distributed with the ICN and marking up the document (in ink) to reflect the changes identified on the ICN.

SECTION C - Identify if personnel will be affected by the change and include a brief description of the effect. If there is no effect on personnel (e.g., the change was made to clarify the intent of the procedure or to correct a typographical error) this block should be marked "N/A."

SECTION D - State the reason for the change followed by a description of the change (including the affected paragraph, information which is deleted, and the actual wording of any replacement test) for each change included on the ICN.

SECTION E - The Project Manager shall document the reason for not obtaining original reviewers approval.

SECTION F - Identify type of change and document required approvals.