Implementing a Change Control Quality System Successfully
Danielle DeLucy, MS, is an 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, and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees, and those wishing to improve compliance to establish more robust quality systems so that the company can succeed.
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 coordination of all change activities will also be discussed.
Learning Objective
- Identify what constitutes a change
- Learn how to properly categorize a change
- Demonstrate how to write/execute a Change control proposal, assessment, and closeout
- Discuss the Establishment of a change control board
Areas Covered
- Overview of change control regulatory requirements
- What is change control? and 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 on products
- Impact to facility
- Impact on 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 Should Attend
- Pharmaceutical professionals involved in the manufacture of products
- All levels of management
- Quality professionals
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