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Reduce Compliance and Recordkeeping Burdens
In this webinar, we will discuss:
- Regulatory Expectations
- How to plan, structure, and implement a quality system
- Common problems and lessons from 483 and warning letters
- Red-flags that your QS is not effective or efficient
- Six essential capabilities for an effective and efficient QMS
- Risk analysis and management techniques
- Process control and performance monitoring
- Culture, Management Responsibility, and maturity
- Strategies for improvement
- Improvement techniques
Overview of the webinar
This 90 minute webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies.An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality.This webinar will get you started in setting up a quality system that reduces compliance burden.We’ll discuss techniques for improving efficiency, reducing burden, and still maintaining an effective QMS.
Who should attend?
- Quality Systems Specialists
- Document Control Specialists
- Quality and Compliance Specialists
- Auditors
- Auditor Managers
- Compliance Managers
- Quality Managers
- CAPA Specialists
- Quality and Compliance directors for Medical Device companies
- General Managers and Executives wanting to use Compliance and Quality as a competitive strength
Why should you attend?
This webinar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You’ll learn to recognize sources of inefficiency in your QMS.
This seminar can help you get your quality system off to a good start and avoid common, but serious, problems including MDRs, recalls, 483s, and warning letters!
The expectations for quality and compliance continue to increase.We will discuss changing regulations and expectations and what you can do to prepare for them.This seminar will allow you to interact personally with an industry expert with over 30 years’ experience in medical devices.The instructor has worked in manufacturing, design, quality and compliance at industry leaders like GE, Johnson and Johnson, and Medtronic.She has traveled throughout the world developing, auditing, and improving quality systems.
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.