Implementing Successful Change Control Systems

This training program will help identify what constitutes a change and demonstrate how to write/execute a change control proposal, assessment and close out. The course will also discuss the establishment of a change control board.

Why Should You Attend:

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. This course will provide attendees with the proper tools and information to build a robust change control quality system that will withstand the scrutiny of a FDA or regulatory inspection.

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

Areas Covered in the Webinar:

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 Will Benefit:

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

Instructor Profile:

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.

For Registration - http://www.complianceonline.com/implementing-successful-change-control-systems-and-their-regulatory-requirements-webinar-training-704394-prdw?channel=worldconferencecalendar

Note: Use coupon code NB5SQH8N and get 10% off on registration.