Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

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.

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 21 CFR Part 820.30 (f, g), ISO 13485-2003, and Risk Analysis Techniques consistent with ISO 14971-2007, as well as EN ISO 14971-2012.

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.

Jim Rosa

Specialties: Medical Devices, Regulatory

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.  With roots in research and development and conversion to quality systems oversight later in his career, Jim provides a solid understanding and perspective from engineering and quality in bringing products to market in the medical device and IVD industries.  The blend of working with research & development and quality system function, in the EU and US, in startups and large companies provides a unique insight into the practical application of design control for medical devices.  Jim also has four patents related to medical device safety system implementations.  Jim has worked for Gambro, Intel, Reglera, Dohmen and a number of start-ups such as CeMines (IVD) and FibroTx(IVD).

Jim’s recent focus has been on Systems & Software within the medical device market, driving strategy and implementation efforts for traditional electromechanical, mobile applications, wireless applications, infrastructure software devices, and software as a device.  Additionally, Jim has taught Design Controls, V&V, and Risk Management at the University level.

Mr. Rosa has earned degrees from Colorado State University (MBA) and the Radford University (BSCS).