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Figure 4: Phase I – Project Initiation

Corporate Involvement

Start Phase I

Initiation

Thousand Oaks Project Support Supervisor Receives the Projects Approval Status Matrix Email from the IBOB Administrator

Thousand Oaks Project Support Supervisor Notifies the Satellite Group of Project being Approved

Satellite Staff Consults the PM about the Scope of the Services Needed and Assigns the PC Rep

Manufacturing or GMP Project?

Yes

No

Satellite Involvement

Minimum

PC Attends the Project Kick-Off Meeting:

  • Develops the relationship with A/E and GC

  • Delivers the minimum project documentation (TOP) requirements to the PM, A/E and GC

PM Decides on the Level of DC Support

Full

PC Negotiates the Scope of Services with the PM:

  • Establishes supported docs baseline

  • Designs the docs flows

  • Defines the admin support requirements (scheduling, meetings, travel, etc.)

  • Fine-tunes the docs requirements (TOP requirements) for A/E and GC

  • Requests his/her addition to the project matrix

PC Attends the Project Kick-Off Meeting:

  • Establishes the point of contact with A/E and GC.

  • Delivers the full project support requirements to the A/E and GC, copy to the PM.

Project Support Internal Activity Amgen Internal Activity A/E & GC Related Activity Start or End of Flow Flow Connection Point

PC Prepares the Documentation Support “Infrastructure”:

  • Electronic applications

  • Physical hard-copy folders

  • Hanging file

End Phase I

Process Overview

DC Negotiates the Scope of Services with the PM:

  • Establishes supported docs baseline

  • Designs the docs flows

  • Defines the admin support requirements (scheduling, meetings, travel, etc.)

  • Fine-tunes the docs requirements (TOP requirements) for A/E and GC

  • Requests his/her addition to the project matrix

  • Participates in the establishment and formatting of the Turnover Requirements for the manufacturing, validation and maintenance/ operations

Project Enters Design and Construction Stage. See Phase II

3-3

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