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Made Simple
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Project Management Made Simple:
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Project Management Made
Simple:
Key Principles
Know what you need
Know when you need it
Know what you can
pay
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Project Management Made
Simple:
Guidelines
Priorities Based
Process Focused
Systems Aligned
Systems Integrated
Results Driven
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Project Management Made Simple:
Technical Quick
Connects
One Page Project Process Map
One Page Question to the Void
Worksheet
One Page Project Overview Worksheet
One Page Project Initiating Worksheet
One Page Project Planning Worksheet
One Page Effective Meeting Worksheet
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Project Management Made Simple:
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Project Management Made Simple
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Project Management Made Simple:
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One Page Project Map
Phase I: Initiating Project Phase II:Planning Project Phase III: Executing the Project
Project Vision and
Mission Statements Define the Project Design the
Project Plan
Identify Desired Outcome Explore Causes
Cause-Effect
Diagram
Execute and
Identify Customers Control the Project
Analyze the Opportunity
Identify Customer Collect & Analyze Data
Requirements Type
Size
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1111
1 3
11 6 Evaluate
6 3 9
Pareto Diagram Check Sheet Outcome
Identify Supplier
Specifications
Histogram Run Chart
. .. . . .
Identify Steps in the Process Desired Outcome
Tools: Achieved?
Top-down Flow Chart Yes No Yes
Scatter Diagram Control Chart
1 2 3
Cause
Flow Chart Identified Yes
Identify Choices ?
Document &
No
Standardize
Work Flow Diagram
Select Best-Balanced Quality Systems
Approach
Choice
Monitor
Identify Measures
Project Management Made Simple:
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Project Management Made Simple:
Initiating
Planning
Executing
Controlling
Closing
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Project Management Made Simple:
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Project Management Made Simple:
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One Page Project
Initiating
How
Overview Where
Headquarters
When
First Quarter Sponsor
Who
Members Sponsor/Client
Money Sponsor/Client
Machines Sponsor/Client
Materials Sponsor/Client
Methods Sponsor/Client
Create/Innovate Client/Sponsor
Negotiate Sponsor/Client
Communicate Sponsor/Client/Manager
Motivate Sponsor/Leader/Client
Educate Leader/Sponsor/Client
Administrate Manager/Sponsor/Client
Scoping
Risk Analysis
Scheduling
START: Time______Location______Guests_______
List objectives of This Meeting
_________________________________________________________________
_________________________________________________________________
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CDRH Strategic Plan
Our Mission
Promoting and protecting public
health by ensuring the safety and
effectiveness of medical devices
and the safety of radiological
products
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CDRH Strategic Plan
Our Vision
Ensuring the health of the public
through out the Total Product
Life Cycle (TPLC)
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CDRH Strategic Goals
Goal 1: Public Health Impact
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Strategic
Plan
Goals
Execution &
Evaluation Priorities
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Execution
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How do we execute the strategic
plan?
Project Management Plans
Long term projects
New initiatives
Scorecards
Performance in Key Result Areas (KRAs)
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Meeting MDUFMA Performance
Goals
We're setting 320
milestones
days for review
PMA Received
Clock
Filing Review Stops
Filing Letter
Major
Deficiency Panel Meeting
Letter
Closeout Review
Final Decision
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Quality System for Application
Review
We're using quality systems to assure quality
reviews
Focusing on selected cross-cutting
areas
e.g., biocompatibility
Using retrospective (post-decision)
peer assessments
Assembling quality assessment teams
Continuing with pilot program
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So why do we need a strategic
plan?
Were using strategic planning to meet our
challenges
Managing a changing workload
Meeting changing stakeholder
demands and expectations
Making best use of our limited
resources
Conducting business in an open and
transparent manner
Looking beyond the next fire drill!
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And what do we need from
you?
Awareness
Energy
Ideas
Patience
Support
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Project Management Made Simple
Conclusion
Apply the Key Principles