Regulators now expect that all companies have in place an effective quality management system (QMS). ICH Q10 provides the latest thinking on this area and ISO13485 provides an integrated model for implementing a QMS.
This workshop will enable participants to implement practical QMS elements such as CAPA, design control/transfer, and leverage customer feedback and audits.
Learning outcomes and benefits
On successful completion of this course, participants should be able to:
- Interpret and effectively apply ICH Q10 principles
- Assess and audit their internal or vendor QMS and the associated gaps to best practice
- Demonstrate “linkage” between related QMS elements, particularly CAPA systems
- Develop a highly efficient and integrated quality management system
Suitability
The course is suitable for all supervisors and managers required to work within or manage a QMS in devices, pharmaceuticals, and biologics, for example:
- Quality Assurance/Quality Control personnel and managers
- Compliance and quality systems auditors
- Operations Managers and Quality Engineers
- Vendor assurance personnel and managers
- Personnel responsible for implementing an integrated QMS
Participant's notes, case studies and certificates of successful completion will be provided.