Design Controls are absolutely essential for ensuring the safe and effective production of medical devices. The FDA too considers design Controls a critical process. Yet, design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA. Although intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase; a significant percentage of all medical device recalls are due to design problems, as statistics show.
The implications of poor design of medical devices controls are quite obvious:
- They account for a significant number of recalls
- Design issues can result in complaints and medical device reports
- Design issues can even create manufacturability issues such as low yields and excessive scrap and rework, for companies.
Get an understanding of the solutions and the ways of implementing them
So, the solution to this problem is to find and fix issues early on in the design process. This is a much more effective and inexpensive alternative to fixing problems for products already in production.
The ways of ensuring a trouble-free design control process will be taught at a seminar being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory compliance areas.
The Director at this seminar is Susanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900629SEMINAR to enroll for this seminar.
A valuable all-round learning session
Susanne will help participants understand and develop design controls processes and tools that are compliant with the regulatory requirements and are a competitive strength for their organizations. She will help them learn from past issues and improve their next generations of product.
She will help participants understand the requirements for design controls and how to translate them into an efficient and effective process for their organizations. She will start with the history and requirements for design controls. She will then move on to a discussion of the requirements and tools in detail. This seminar will include exercises to help participants practice and improve their design control process.
The following areas will be covered at this seminar:
- Lessons Learned
- Best Practices
- Inspection Readiness.