Design Controls: What to know when it comes to FDA regulated industry?

This 120-minute webinar will help medical device manufacturers to understand what you need to do to ensure that your process, the methods, and the procedures that you have established to implement the requirements for design controls are in perfect order.

Why Should You Attend:

In the global economy and supplier partnership, it is critical that every product development process for product, service or logistics, is well designed - that the design inputs are well defined, design outputs are documented and auditable as well as design transfers are successful. There are millions of dollars spent on design transfers that are not effective - and instead of creating a benefit and remove liability, they instead increase the liability and risk. There have been number of FDA findings and warning letters issued against the design control processes to all sizes of medical and pharmaceutical manufactures.

This 2-hr session will review the FDA design control requirements under GMP regulations and show how, as a medical device manufacturer, you can design faster, transfer faster, make faster yet never compromised quality and be in full compliance with FDA requirements. By attending this training, you will be in a position to ensure that your process, the methods, and the procedures that you have established to implement the requirements for design controls are in perfect order.

Areas Covered in the Seminar:

• Medical Device, FDA & CFR
• Design Control Introduction
• Design & Development Planning
• Design Input
• Design Output
• Design Review
• Design Verification
• Design Validation
• Design Transfer
• Design Changes
• Design History File

Who Will Benefit:

• Product development engineers
• Quality Engineers
• Quality Managers
• Small business owners
• CAPA investigators
• Project managers
• Consultants
• AdvaMed companies