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Course Description - How to Write and Manage a Change Control System

              Compliance Key INC - FDA compliance training


                                            Danielle DeLucy
Danielle DeLucy, MS, is Keynote speaker at Compliance Key, Inc. She is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle 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.
 Webinar Id: LSHCSDD005
 10:00 AM PT | 01:00 PM ET
 10/24/2017
 Duration 60 mins 
Overview
This webinar 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.
Why should you attend this webinar?
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.  
Areas Covered in the Session:
  • 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 can Benefit:
  • Pharmaceutical professionals involved in the manufacture of products
  • All levels of management
  • Quality professionals

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717-208-8666




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