The Integrated Team

The integrated team will be formed as early in the project sequence as possible. Membership will include but is not limited to the following full-time members  

The Venture Manager, as the business representative to the team, is the leader during the business analysis portion of the FEL. 

Since the preliminary engineering phase is principally process engineering, the Technical Manager is the lead during this phase. 

Project planning is the venue of the Project Manager, who continues to take the lead during the EPC phase. 

Once construction is complete, the Manufacturing Manager takes the lead during the startup phase. 

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Try to select Quality Management tools that the integration team and other staff in your organization are familiar with otherwise invest time in training. 

You can also use the pilot study to provide a training ground for the integration team, with care to avoid overwhelming the subject department with the whole integration team. It is unlikely that you can fmd realistic opportunities to involve the whole team directly. But you may be able to... 

The integration team should review the design and implementation process. This will usually consist of two steps ... 

Al Bickman, Osprey River site manager, expects the work on the pilot study to start next month and be completed within 12 weeks. He has established a local team of managers, engineers, and operators to work with the integration team. Most of this team will be committed for up to half of their time. The team leader will be dedicated to the project. 

The successful IND is most likely a result of cooperative work with an integrated team represented by Regulatory, Quality Assurance, Clinical, CMC, and others. Quality Assurance, for example, is likely to have valuable input into the design of the Investigator s Brochure Clinical can contribute important direction and focus to the literature review Regulatory may have CMC input of value and so forth. The integrated team is more likely to both produce a smoothly integrated document and assure that the content of that document represents a cohesive and systematic assurance of public safety, which is the primary FDA focus. 

Second, the integrated team can provide immediate and multiperspective feedback on all sections of the IND. The varied experiences of team members can help with questions and issues that extend beyond designated areas of responsibility. 

Finally, the integrated team approach mimics and hence best meets the FDA review process. While a variety of FDA groups have input into an IND review, those subunits meet in a committee format to discuss and evaluate the submission. As a result, a number of their questions and concerns represent... 

The integrated team is most likely to prove efficient, effective, and successful in IND (and other regulatory) submissions. 

The Venture Manager helps the integrated team focus their energies towards accomplishing the project s goals. Specifically, these actions will be concentrated in ensuring ... 

The integrated team members are identified and made available for the duration of the project. 

The integrated team can adequately represent all the major stakeholders of the project. 

Coordination procedure. This shows, in writing, the responsibilities and authorities of each of the integrated team members. A sample of one of these appears in Appendix C. 

HELPING THE INTEGRATED TEAM AVOID THESE SITUATIONS CAN BE THE HARDEST PART OF THE VENTURE MANAGER S JOB. 

Notice, the objectives have not said anything yet about how the improvement in quality will be accomplished. The project goal is to improve profits through quality improvement. Making sure the integrated team understands this difference is critical. The goals should be stated in the most basic terms. 

The sensitivity analysis gives the impact of not meeting the assumptions. The next analysis determines the likelihood of the unprofitable event occurring. As in the sensitivity analysis, the combined knowledge of the integrated team and their assistants will be required to effectively answer the question of likelihood. 

The contractor s Project Manager can become a veiy valuable addition to the integrated team. 

The Project Manager is still the lead of the integrated team during this period. All members of the startup team help in this activity under the direction of the Project Manager. 

The lead of the integrated team passes to the Manufacturing Manager and the Startup Manager during this period. 

Ideally, the Project Startup Manager should be the integrated team s Manufacturing Manager and has been through the design effort and thus is... 

Locate resources (by name) and free them to join the integrated team as soon as possible. 

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