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Six Sigma for Quality and Compliance
This 90 minute webinar will focus on using CAPA to improve your product quality and compliance. Topics to be covered include:
- FDA and NB expectations for CAPA / Improvement
- Lessons Learned from 483s and warning letters
- Common problems and simple solutions
- The CAPA process
- Six sigma methodology and a toolkit for CAPA
- DMAIC process and tools
- Root Cause Analysis
- Failure Investigation
- Stand-alone documentation
- Best Practices
- Inspection Readiness
Overview of the webinar
FDA regulations require medical device companies to have a suitable and effective Quality Management System (QMS).And Corrective and Preventive Action (CAPA) is an important tool to address problems within the QMS as well as product quality.The international standard ISO 13485:2016 makes it clear that corrective and preventive actions fall under the heading of Improvement.Yet, many companies don’t have a methodical process or tools for improvement. Not only do they fail to achieve necessary improvements, they waste precious time and resources.This webinar will help you avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.Six sigma tools and methodology provide a rigorous approach to improving quality and compliance results.
Who should attend?
- Quality Systems Specialists
- Document Control Specialists
- Quality and Compliance Specialists
- Internal Auditors and Managers
- Training Specialists
- CAPA Specialists
- Project Managers
- Supplier Quality Engineers and Auditors
- Quality/Compliance managers or directors for Medical Device companies
- General Managers wanting to learn how to understand Quality System requirements
Why should you attend?
CAPA and improvement are the foundation of an effective Quality Management System.Many companies struggle to improve quality and compliance because they lack simple tools.An ineffective CAPA System leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters.And an inefficient improvement process results in wasted time, money, and missed opportunities.In this 90 minute webinar, we’ll discuss the fundamentals of an improvement process and how that fits into CAPA.
Learning Objectives
- Overview of the Regulations
- FDA Expectations
- CAPA and Improvement
- Six sigma tools
- Root Cause Analysis
Faculty - Miss.Susanne Manz
Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.