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 (ICH Q10, ICH Q9, ICH Q13) behind such changes. You will also learn about smart strategies for the management and which systems are linked with these systems. This course is rounded off with a workshop and with practical case studies, as well as interactive discussions with colleagues from pharma, biotech and medical device industry.
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
- Hot topic: Update of Annex 1 and its consequences on process and equipment changes
- Case studies for significant changes and follow-ups:
- Change of a testing equipment in the laboratory and a change of a manufacturing equipment in a manufacturing line for sterile products with the related qualification and validation activities
- New Annex 1 Case study from a manufacturing and engineering perspective
- Big Workshop with an example directly from practice: Implementation of a new equipment in the packaging process
- New breakout sessions during the course: You ask – the group discusses. Selected questions during the course will be discussed in the middle and at the end of each day to have an interactive course and to hear different opinions to a specific challenge
Who should attend?
Specialists and managers from the solid, biotechnological and from the medical device industry:
Quality Assurance and Quality Control Manager, Pharmacovigilance, Regulatory Affairs Manager, Experts from the Engineering Departments, 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 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
