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How To Manage Outsourced Contract

Analytical Resources

ABOUT THE COURSE

"How To Manage Outsourced Contract Analytical Resources" is a solid, one-day course which focuses on the little recognized fact than in the pharmaceutical industry outsourcing contract analytical work may be one of the most difficult tasks to undertake. Many times, the sponsor who is outsourcing work (for the first time) takes an almost casual attitude with respect to choosing a contract laboratory and managing the entire outsourcing process. If the approach is not casual, time constraints may also limit the seriousness of the undertaking. Regardless this is a very risky approach, in that there are numerous companies (some of which whom are no longer in existence) who blindly submitted results generated by a contractor to FDA only to have it rejected as unsatisfactory.  This course is designed to give suggestions on how to address these and other shortcomings which are more commonly seen in the analytical laboratory outsourcing world. The instructor with specifically addresses: establishing structure, systems, and defining functions for outsourced projects.  

WHO SHOULD ATTEND

This course was specifically created for laboratory managers and support staff who are involved with contracting and outsourcing analytical resources. 

COURSE OUTLINE

1.      Overview of Outsourced Contract Laboratory Resources

2.      Roles and Responsibilities                                                                        

3.      The Workflow Plan                                      

4.      The Communication Plan                        

5.      The Technology Transfer Plan                 

6.      The Contractor Sourcing Plan

7.      The Documentation Plan

8.      The Training Plan

9.      The Project Management and Monitoring Plan

10.  Summary

11.  Questions and Answers

ADMINISTRATION

The course is one day in length. Cost is $525 per person, with a ten-student minimum for on-site presentation. Payment can be made by personal check, company check, purchase order, or by MasterCard, Visa, or American Express. Registration can be made on-line or via telephone.

 

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