COURSE DESCRIPTION

OVERVIEW

In the highly-regulated world of pharmaceutical and biotech product manufacturing, it is imperative that projects from facility qualification and scale-up to quality control and batch review are completed efficiently and effectively.  The difference between success and failure of your manufacturing efforts is often due to poor project execution.  Production delays lead to loss of profits, and a sound foundation in project management can help prevent this.

This course is designed to introduce a very practical, systematic approach for project execution with a view to improving the productivity, quality and minimizing rework.  This will be a very useful guide for the completion of project scope definition with regard to design status and project execution plan before the project is submitted for approval by the appropriate management. Course content will focus on the application of various project management tools and techniques available (PMP/PMI) in a sequential manner as a recipe for overall project success with regard to cost, schedule, safety, operability and validation of your facility for regulatory approval.

LEARNING OBJECTIVES

During this 90-minute session you will learn:

• Critical steps for initiating a project – who, what, and when
• Key areas where projects fail in a pharma/biotech manufacturing environment: Avoiding pitfalls
• Specific ways to apply PMI PMBOK principles to a pharma/biotech manufacturing environment
• Important pieces for project close-out and review

The course will cover the following important steps for any successful project execution as follows:

• Four steps for project execution in general
• Project Risk Assessment ( Step 5 )
• Value Management ( Step 6 )
• General Lessons Learned for any project execution
• General Recommendation