Process and Equipment Change Management

Summary

Changes of equipments and manufacturing processes, but also of analytical processes are on top of the agenda in the world of digitalization. These quality systems are time and material consuming, so there is a need for the implementation of smart management strategies. In this 3 day course the basics of the management of significant equipment and process changes is presented and discussed, as well as the regulatory background behind such changes.

Learning Objectives

• Implementation of correct management of significant changes of equipments
• Learn about the management of significant changes of manufacturing and analytical processes
• Understand the regulatory requirements behind the changes
• What are the systems linked to the change management?
• Practical Case Studies
• Big Workshop
• Interactive discussions with colleagues from different pharmaceutical areas

Key Topics

• Smart management of equipment changes and smart qualification strategies
• Smart management of process changes and smart revalidation strategies
• Regulatory background behind such changes
• Deviation, risk and audit management
• Case Studies for significant changes and follow-ups
• Workshop with an example directly from practice

Who should attend?

Quality Assurance and Quality Control Manager, Pharmacovigilance, Regulatory Affairs Manager, Process Validation Specialist, Manufacturing Management, Process Development, Research and Development, Certified Management Consultant

Our online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer
• Q&As, case studies, polls
• Revisit recorded sessions for 30 days
• Training in digital format
• Digital and LinkedIn certificates