Throughout the device industry, many instances of corrective and preventive action occur, as manufacturers continually evolve processes, procedures and technology in order to ensure each product meets the highest possible quality standards. From initiating a CAPA through to closing out the CAPA in a timely manner, quality system leaders must remain involved in each step of the process in order to document changes, and to investigate the root cause in order to ensure the incident is prevented in the future. Exploring best practices in handling CAPA events will ensure leadership has a robust understanding of how to handle these situations across the organization. Since CAPAs require significant resources and time, it is imperative that they be done correctly the first time. One method of achieving this is through the use of intuitive quality design. This approach takes the requirements and options out of procedures and work instructions and put them into forms, tools, and templates. Intuitive quality design can be used to create a CAPA system to reduce overall cycle time, improve effectiveness and eliminate repeat CAPAs.
- Proper identification of CAPA inputs
- Conducting root cause analysis of CAPA events
- Streamlining CAPA actions to reduce timelines
- Verifying the effectiveness of CAPA actions
- Sharing lessons from CAPA across the organization
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Quality Systems
- Quality Systems Engineering
- Regulatory Affairs
Ryan Hagemeier is currently the QA/RA Director of Global Quality Systems at Hill-Rom. He is part of the Quality Leadership Team based in Batesville, Indiana and is responsible for implementation and oversight of the corporate Quality Management System, with specific focus on CAPA, Document Control, Training and Quality Metrics. Prior to joining Hill-Rom, Ryan spent 5 years working for GE Healthcare in Wisconsin where he held multiple roles within the Quality Organization (CAPA Leader, Production & Process Controls Manager, Quality Management Systems Manager). Overall, his background includes over 15 years working within the healthcare industry either through research, manufacturing, or quality assurance. Ryan holds a BS in Biology from Gustavus Adolphus College in Minnesota.