World Conference Calendar

34483 Conferences

Developing and Implementing an Effective Change control Procedure in the Pharmaceutical Laboratory

Added by Referral on 2011-07-05

Conference Dates:

Start Date Start Date: 2011-08-25
Last Date Last Day: 2011-08-25

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email:
Address Address: 2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

Why Should You Attend:

This course is designed to provide participants with an understanding of regulatory requirements for Change Control as they relate to the Pharmaceutical Laboratory, and information which will be helpful in designing and implementing a procedure which addresses those requirements.

Practical examples and a review of some recent FDA Warning Letters and 483's will be included.

Learning Objectives:

Upon completion of this course the learner should be able to:

- Understand the regulatory basis for Change Control, with emphasis on how they relate to the Pharmaceutical Laboratory.
- Understand the key components in change control: Who, What, When, Why
- Identify the key elements which should be included in a Change Control SOP
- Identify benefits of effective Change Control and strategies to maximize efficiency
- Effectively prepare for an FDA inspection as it relates to Change Control
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