Implementing a Change Control Quality System Successfully
Learn to categorize changes, write and assess change control proposals, set up a change control board and close out changes with proper documentation.
Speaker
Danielle DeLucy
Pharmaceutical quality consultant · ASA Training and Consulting, LLC · MS
Overview
Change control is a key element of any quality management system. This 60-minute change control training covers the fundamental steps and processes, from the change proposal through assessment, execution and final implementation.
You'll learn the regulatory basis for change control, which changes it covers, such as like-for-like, specification, facility, equipment and emergency changes, and how to design the system. The session explains what a proposal should include, how to assess risk and impact on products, facilities and regulatory filings, and how to set up a change control board with clear responsibilities, action items and deadlines.
It also covers closing out a change, checking its effectiveness, and hard copy versus electronic documentation.
Why attend: Changes to processes, equipment, facilities, materials, suppliers, test methods and specifications must be managed to prevent unintended consequences and meet regulatory requirements. Poor change control can cause serious compliance and product quality problems. This session suits pharmaceutical manufacturing staff, quality, QA, compliance and regulatory professionals, R&D and engineering staff, change control reviewers and approvers, supply chain managers and managers at all levels.
What’s covered
- What change control is and why it matters
- Types of changes: like for like, specification, facility, equipment and emergency changes
- Proper documentation
- Elements to include
- Risk and impact on products, facilities and regulatory filings
- Developing a change control board and board member responsibilities
- Setting action items and deadlines
- Final implementation and how to close out a change
- Effectiveness of the change
- Hard copy and electronic change control systems
Who should attend
What you get
About the speaker
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. 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 establish more robust quality systems so that the company can succeed.
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