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This webinar will help you to develop a Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient. The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured”. This webinar will cover the basics of how to establish and maintain a suitable QMS including:
- The basic requirements
- Management Responsibility
- Quality Audit
- QMS structure
- Quality Policy
- Quality Manual
- Standard Operating Procedures
- Work Instructions
- Forms, Templates, Records, etc.
An efficient, effective QMS sends a message to the FDA and other regulators that your QMS is complete, accurate, and consistently followed. More importantly, it ensures that your personnel can consistently and accurately meet requirements resulting in correct outcomes and quality work.
Why Should You Attend:
An in effective QMS can lead to serious compliance and quality issues including 483 observations, warning letters, and even consent decrees. Even worse it can lead to inconsistent of poor product quality including non-conformances, complaints, and even recalls. And an inefficient QMS leads to confusion, inconsistency, excessive rework, corrective and preventive action, and increased cost of quality. This webinar will help you understand the warning signs and create a strategy and action plan for improvement
- Overview of the Regulations
- FDA Expectations
- Lessons Learned and Common Mistakes
- Best Practices
- Preparing for an FDA Inspection
This 90-minute webinar will include:
- FDA expectations
- Lessons Learned from 483s and warning letters
- Common problems, mistakes, and warning signs
- How to structure your QMS
- Quality Policy and Manual requirements
- QMS Documents and Hierarchy
- Management Responsibility
- Best Practices
Who Will Benefit:
- Quality Systems Specialists
- Document Control Specialists
- Quality and Compliance Specialists
- Internal Auditors and Managers
- Training Specialists
- CAPA Specialists
- Designated Management Representatives
- Quality/Compliance managers or directors for Medical Device companies
- General Managers wanting to learn how to understand Quality System requirements
- Subject Matter Experts who write procedures
Susanne Manz, MBA, MBB, RAC, CQA 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.
While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.