Implementing a Change Control Quality System Successfully
About This Event
Implementing a Change Control Quality System Successfully
Quality Systems
Instructor: Danielle DeLucy
Product ID: 501203
Level: Intermediate
Description
This web training session is designed to help attendees understand the fundamental change control steps and processes. The expert trainer will focus on change proposals, assessments, execution and final implementation of a change control quality system. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.
Objectives of the Presentation
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
Why Should you Attend
During this course, the speaker will explain the regulatory basis for change controls, the steps in designing a change control system, and the types of documents or processes that are subject to change control. After completion of this course, you will be able to implement immediate steps in executing a change control form.
Areas Covered
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
Who can Benefit
Pharmaceutical professionals involved in the manufacture of products
All levels of management
Quality professionals
Compliance Officials
Quality Assurance Personnel
For Regsitration -
http://www.onlinecompliancepanel.com/webinar/QUALITY-SYSTEM-501203/JAN-2016-SB-WORLDCONFERENCE
Note : Use coupon code 1371 and get 10% off on Registration