Jim Rosa provides quality engineering guidance to companies for the development, management and operation of quality systems for devices. He has 40 years of experience leading R&D and quality functions within regulated industries.
Course runs 9:00 - 5:00 on Day 1 & Day 2 (Breakfast & Lunch Included)
This medical device risk analysis, validation, and verification course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to V&V and Risk Analysis and the FDA's supplemental guidelines. An ISO perspective is offered to compliment the FDA view.
Upon completion of this course, attendees will have an understanding of the framework for Design V&V, Risk Analysis and recommendations to effectively meet the regulatory requirements relating to these. Emphasis will be placed not only on regulatory aspects, but on effective strategy, which is very important to avoid spending unnecessary time and money on ineffective techniques while ensuring that the requirements for medical products are met successfully.
The first day will cover the general context for V&V and Risk Analysis in relation to quality systems, standards, and procedures. The course will then focus on implementation aspects of key parts of V&V which will continue into the second day. Attendees will participate in several exercises designed to reinforce key concepts from the presentation. Participants will receive extensive course notes that can be used as reference material once the course is completed.
