Implementing a Change Control Quality System Successfully

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.

• Identify what counts as a change
• Categorize a change correctly
• Write and execute a change control proposal, assessment and close-out
• Assess the impact of a change on products, facilities and regulatory filings
• Set up a change control board with clear responsibilities
• Check that a change was effective

Change control regulatory requirements

• What change control is and why it matters
• Types of changes: like for like, specification, facility, equipment and emergency changes

Change control proposal

• Proper documentation
• Elements to include

Change assessment and approval

• Risk and impact on products, facilities and regulatory filings
• Developing a change control board and board member responsibilities
• Setting action items and deadlines

Implementation and documentation

• Final implementation and how to close out a change
• Effectiveness of the change
• Hard copy and electronic change control systems

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.

• Pharmaceutical professionals involved in the manufacture of products
• All levels of management
• Quality professionals
• Compliance Officials
• Quality Assurance Personnel
• Regulatory Affairs
• R&D and Engineering Staff
• Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)
• Supply Chain Managers

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.