Below is the summary and description for my project I am going to present. I need to Develop a detailed project budget and a baseline plan (Earned Value Method). Develop a cost control plan for this project . I also need in detail of Activity costs, Detrmine project budget, Aggregated total budget cost (TBC) in work breakdown structure method. and also develop the cumulative budget cost. Determine actual cost also.

1. Executive Summary

The purpose of this document is to define and document all pertinent elements regarding the following proposed and approved project for utilization by Valley Pharmaceuticals:

VAL1234 - Validation of LR-Z Series SensorManufactured by Stevens Inc.

Valley Pharmaceuticals is a pharmaceutical company governed by the Food and Drug Administration (FDA) based in Hoboken, NJ. Per FDA and regulatory guidelines, Valley Pharmaceuticals manufactures, markets, and distributes pharmaceutical-grade medication both domestically and internationally. As of 2010, Valley Pharmaceuticals is approved by the FDA for the production and distribution of Jamflustatin, a flu vaccine contained within a pre-filled syringe.

Currently, the production process of Jamflustatin utilizes the LR-X Series Sensor manufactured by Stevens. Inc. It is used within the final packaging processes for quality inspection of the final product. The purpose of this project is to validate the upgraded LR-Z Series Sensor, also supplied and manufactured by Stevens Inc., for implementation into the Jamflustatin production activities. The upgraded product is an all-purpose sensor capable of universal change detection and position-based detection for a wide array of materials. An additional feature of the LR-Z Series Sensoris its ability to measure liquid volume within a container in a very short time.

Upon completion of the proposed project, the LR-Z Series Sensor will replace the LR-X Series Sensor in the quality packaging inspection process as part of the production of Jamflustatin. The implementation of the new sensor will follow all government and regulatory guidelines. All validation documents and data pertaining to this project will be accessible to the FDA.

1. Project Description

Currently, the LR-X Series Sensor is utilized within the quality inspection process during the packaging stage. As each syringe moves down the production line towards the packaging box, the LR-X Series Sensor uses a laser to determine if the product syringe is present on the line and if there is solution in it. If there is no syringe present, the line will automatically stop for review and adjustment by the packaging supervisor. If there is no solution in the syringe, the syringe will automatically be ejected from the packaging line and segregated to ensure it will not be packed and distributed to customers. Although it cannot detect the chemical and biological composition within the syringe solution, the LR-X Series Sensor helps to ensure that faulty or non-quality product is not distributed to customers while maintaining an efficient packaging run time frame.

The LR-Z Series Sensor has all the abilities of the LR-X Series Sensor, however it has an additional feature in which the scan is able to determine the volume within the container and in a shorter time frame per syringe. The LR-X Series Sensorcan scan, collect data, and determine if the syringe is accepted or rejected within 5 seconds by checking for the presence of a syringe filled with solution. The LR-Z Series Sensor can perform these activities and determine volume within the syringe in less than 3 seconds. The replacement of the LR-X Series Sensorfor the LR-Z Series Sensor would improve process efficiency and increase product output for Valley Pharmaceuticals because approximately 2 seconds would be saved per syringe. For a final packaged lot with a large amount of individual units, company time and money would be saved. Furthermore, it is feasible for those resources to be redirected to producing more products. In addition, the new sensor collects more data on the quality of the final product. As a result, there may be less faulty products distributed to customers because an additional product quality criterion is added to the packaging inspection process.

As per FDA guidelines, for purposes of marketing and distribution, "a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards." As of 2010, Valley Pharmaceuticals is approved by the FDA for the manufacturing, distribution, and marketing of the flu vaccine, Jamflustatin.Per additional FDA guidelines, "application holders must notify FDA about changes to conditions established in approved applications beyond the variations already provided for in their applications...the reporting category for a change is based on the potential risk for the change to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product."

The proposed implementation of the LR-Z Series Sensorand replacement of the LR-X Series Sensor is not considered an FDA post-approval application change as the change is minimal and does not risk the potential of an adverse effect on the distributed product. However, published FDA regulatory guidelines and practices state that all changes need to be documented and prove that the equipment operates as intended and accurately and that the change does not adversely affect the product quality. To continue product distribution with FDA approval, the FDA routinely audits all pharmaceutical companies during their routinely scheduled production and business activities. Within the audit, FDA auditors can request any document they would like including any equipment, process, or document changes and implementations made within Valley Pharmaceuticals. Insufficient responses to the FDA audit may result in a public Form 483, a warning letter, and/or revocation of Valley Pharmaceuticals' permission to produce and distribute Jamflustatin.

The proposed project will ultimately produce adequate and sufficient validation data and documentation for the replacement of the LR-X Series Sensorto the LR-Z Series Sensorwithin the FDA approved production process of Jamflustatin.After this project is complete and the LR-Z Series Sensor is deemed adequate for the production of Jamflustatin, the upgraded scanner can be physically implemented into the packaging line for quality inspection.