The Center for Professional Innovation & Education

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Who Should Attend
This course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers needing an understanding of Validation and Verification (V&V) per FDA’s CFR 820.30(f, g), ISO 13485-2003, and Risk Analysis Techniques consistent with ISO 14971-2007. 

Personnel involved in product development, design, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of Design V&V, Risk Analysis, and its workings, will benefit from this course. Additionally, this program can be customized and delivered on-site for more experienced personnel (including middle and upper management) to update and broaden their knowledge in these subjects.

Learning Objectives
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.

Course Description
This 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.

Among the topics to be discussed are: Context of V&V and Risk Analysis within the overall quality system and regulation, V&V and Risk analysis procedures, V&V methodologies, V&V strategies, types of risk analysis, risk mitigation, and methods to determine probability and severity for Risk analysis.