Live Webinar Implementing a Change Control Quality System Successfully
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute
Webinar Includes : All the training handouts , certificate by the speaker ,Q/A and 60 mins Live Webinar
"Hear By Danielle DeLucy, MS, 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."
This 60-minute accredited online training 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 coordination of all change activities will also be discussed.
Who Should Attend?
This online training course is intended for all Pharmaceutical professionals involved in the manufacture of drugs and drug products. It will be beneficial for all levels of management along with quality professionals.
• Overview of Change Control Regulatory Requirements
o What is Change Control?/Why Change Control?
o Types of Changes Subject to Change Control
o Like for Like
o Specification changes
o Facility Changes
o Equipment Changes
o Emergency Changes
• Change Control Proposal
o Proper documentation
o Elements to be included
• Change Assessment (Risk, Impact) and Approval to Execute
o Impact to products
o Impact to facility
o Impact to Regulatory Filings
o Change Control Board Development
o Areas of Responsibilities for Board Members
o Establishing Action Items
o Establishing Deadlines
o Final Implementation of Change
• How to close out a change
o Effectiveness of the change
o Change Control Documentation
• Hard copy systems
• Electronic systems
Who will Benefit
Pharmaceutical professionals involved in the manufacture of products
All levels of management
Industries who can attend
This online training course is intended for all Pharmaceutical professionals involved in the manufacture of drugs and drug products. It will be beneficial for all levels of management along with quality professionals