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Qualification of New Vendor for Silicone Tube
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bl Milestone Description M T W T F S S M T W T F S S M T W T F S S M T W T F S S M T W T F S S M T W T F S S M T W T F S S M T W T F S S
cel Category Assigned To Start No. Days
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A3 Change Control
4.
Vendor Meeting Completed 4/1/2019 1

CCRB Completed 4/1/2019 1

Change Control approval Delayed 4/2/2019 3

Feasilibility Study

Protocol preparation Inprogress 4/4/2019 2

Protocol Approval Proposed 4/5/2019 1

Execution Proposed 4/6/2019 1

Report Proposed 4/8/2019 1

Risk Assessment

Preparation Proposed 4/6/2019 3

Approval Proposed 4/9/2019 1

PHASE I

Protocol preparation Proposed 4/10/2019 7

Approval Proposed 4/17/2019 1

Execution Proposed 4/18/2019 25

Report Proposed 5/13/2019 5

Supplier Qualfication

Identification form Proposed 4/2/2019 1

Supplier & TSE questionre Proposed 4/8/2019 5

Supplier Audit, Report

preparation & Capa response Proposed 4/15/2019 33
closure
Quality Agreement Proposed 5/20/2019 4

Approved Vendor List Proposed 5/24/2019 1

QC Specification

Change in silicone tubing

Proposed 5/20/2019 5
specification