Event Date/Time: Dec 11, 2003 End Date/Time: Dec 11, 2003
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Description

A full day intensive seminar designed to help validation professionals prepare and implement effective master plans.

The seminar outlines the fundamentals of master planning as frequently employed in the coordination / definition of validation activities. It will also outline recommendations for the establishment / operation of a validation program. This intensive seminar provides a wealth of information for those working in validation to help them understand how best to utilize their resources when developing a master plan.

Why Master Plan Validation?

SCHEDULE FOR
DECEMBER 11, 2003

8:30 Morning Coffee and Registration
9:00 Seminar begins
10:30 30-minute Refreshment Break
12:00 Lunch for Delegates and Seminar
Leader
1:15 Seminar Resumes
3:15 30-minutes Refreshment Break
5:00 Seminar Concludes

Management tool
Project training
The foundation of the validation program
Defines basic procedures to be used
Provides protocol outlines
Assists in determining requirements
This seminar will cover:


Sterile
APIs
Biotech
Solid dosage forms
Clinical manufacturing facilities
Included elements in the validation master planning seminar are:

Why and when should a master plan be developed
What information is needed to start master plan development
What are the necessary elements of a master plan
Extracts of master plans for a variety of projects (sterile / non-sterile pharmaceuticals, API, biotechnology, and development facilities) will be used to illustrate the elements of a plan.
Proven techniques for the management of a validation activity within an organization with discussion of organizational options, prioritization of projects, working with contractors, project tracking, etc

Venue

Types