Date :
Place : United States, Salt lake city
Contact Person:John Robinson
Description:
In this seminar, we will cover Design Controls for medical devices. We will understand the requirements for design controls and how to translate them into an efficient and effective process for your company. We'll cover the history, context, and requirements for design controls. Then we'll discuss requirements and tools in detail and include exercises to help you practice and improve your design control process.Deadline for abstracts/proposals : 11th April 2017
Organized By :Netzealous LLC
Keynote Speakers : Susanne Manz, Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc., 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 industry leaders like GE, J&J, and Medtronic, Susanne worked in various world-wide roles inc
Conference Highlights :Lecture 1: • Overview and Expectations • Background of FDA regulations • Design Controls as an integrated part of New Product Development Lecture 2: • Design Planning • Project Management • Design Inputs Lecture 3: • Design Outputs • Tools, forms, documents Lecture 4: • Design Verification and Validation o Concepts o Strategies o Statistical techniques Day 2 Schedule Lecture 1: • Design Review • Design History File • Documentation Requirements Lecture
Venue :Hilton Garden Inn Salt Lake City Airport 4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA
Check the event website for more details.