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.
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.
Change control regulatory requirements
Change control proposal
Change assessment and approval
Implementation and documentation
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.
Change control regulatory requirements
Change control proposal
Change assessment and approval
Implementation and documentation
Danielle DeLucy
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 …
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