Document Status: DRAFT

Logo Document Title: Corrective and Preventive Action (CAPA) Progress Tracking Form
Document Number:

CAPA # TITLE
Project Lead: Updated: Target Completion Date:

Schedule 2015 (weeks)

CAPA Teams Status 1/5 1/12 1/19 1/26 2/2 2/9 2/16 2/23 3/2 3/9 3/16 3/23 Phase Specific CAPA Summary and Notes
Identification

Evaluation

Investigation

Resolution Plans

Implementation

Effectiveness

CAPA Legend Status Legend

Completed On track
Active At risk
Overall Status of CAPA Project
Future Late

CAPA Project Objectives Key Milestones

Problem Statement: Accomplished (in the last two weeks):

Objective: Planned (for the next two weeks):

CAPA Project Risks Key Issues

Technical: Escalation

Schedule:

Awareness:
Budget:
USDA Product License Project Status Summary - AIV RNA Test Kit AB-Austin
Project Manager: Jeff Zinza Updated: 7/2/09

Schedule 2008-2010
Project Teams Status N-08 D-08 J-09 F-09 M-09 A-09 M-09 J-09 J-09 A-09 S-09 O-09 N-09 D-09 J-10 F-10 M-10 Projects Summary
Submit Outlines/ Submit USDA Product/Site
USDA Product License program overview and major Milestones
Project Overview Plan/infrastructure
Mfg builds BVD PLS Mfg builds AIV PLS? Field Study
Report
USDA Data Eval
Licenses

Prepare, Review, and Submit Outlines of Production (OP) and

*Project timeline extended 3

Outlines of Special Outlines to the USDA for AIV RNA Test Kit. OP details

months due to Fillmore-A

Production and prep. and testing of kit specific reagents. Special Outlines
Special Outlines details prep. and testing of generic kit reagents.

Secure IBC (Institutional Biosafety Committee) approval to

receive pathogenic material (if applicable). Develop,

priority project
Manufacture, and Validate Potency Panel for testing of USDA
Potency Panel licensed product (AIV). Potency panel ensures batch to batch
consistency w/respect to Sensitivity and Specificity.

Manufacture of Pre-License Serials: Includes Product

Manufacture of Pre- Infrastructure, Manufacturing Documentation, Ensuring
License Serials Readiness for build, Manufacture, and QA regulatory review.

Generation of data sets to support product licensing. Includes

Field Efficacy Study, Cross-Reactivity Study, and Thermal
Field Study and Cycler Equivalency Report. Requires identification of
Supplemental Data collaborators and securing regulatory authorizations to
Sets perform study. Protocols and Reports to be filed with the
USDA.

Involves generation of Kit Box and Container (tube) labeling,

Licensed Product Technical Manual, and Supplemental (licensing) labels that
Labeling meet USDA requirements for USDA Licensed Product.

Project Legend Status Legend

Completed On track
Active At risk
Future Late

Project Objectives Key Milestones

Problem Statement: Accomplished (in the two weeks):

Objective:

Planned (for the next two weeks):

Success Criteria:

Project Risks Key Issues

Technical: Escalation

Schedule:

Awareness:
Budget: