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Implementing a Change Control Quality System Successfully

01.00 PM 
10777 Westheimer Suite 1100, Houston, Texas, USA,
Houston Texas

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This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.

Learning Objectives:

Identify what constitutes a change
Learn how to properly categorize a change
Demonstrate how to write/execute a Change control proposal, assessment and close out
Discuss the Establishment of a change control board

Who Should Attend:

Pharmaceutical professionals involved in the manufacture of products
All levels of management
Quality professionals

Course Outline (List in bullet format, not sentences):

Overview of Change Control Regulatory Requirements
What is Change Control?/Why Change Control?
Types of Changes Subject to Change Control
Like for Like
Specification changes
Facility Changes
Equipment Changes
Emergency Changes
Change Control Proposal
Proper documentation
Elements to be included
Change Assessment (Risk, Impact) and Approval to Execute
Impact to products
Impact to facility
Impact to Regulatory Filings
Change Control Board Development
Areas of Responsibilities for Board Members
Establishing Action Items
Establishing Deadlines
Final Implementation of Change
How to close out a change
Effectiveness of the change
Change Control Documentation
Hard copy systems
Electronic systems

Webinar includes:

Q/A Session with the Expert to ask your question
A copy of the PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance

Note:?Use?coupon?code????and?get?15% off?on?registration.
Phone: 8777824696
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Please note: The information on this site is submitted by users. CanadianDesi never checks accuracy of the information. Please use this information at your risk. If you have any question or concern regarding this listing, or you know that the above information is not accurate, please Contact Us. Thanks. 

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