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.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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.
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.
Frequently Asked Questions
Is the course different than the Design Control Course?
Yes. The Design Validation, Verification, and Risk Analysis course provides a deeper, narrower, and more strategic look at the topics of Validation, Verification, and Risk Analysis as compared to the Design Control course. The Design Control course covers greater breadth and a more comprehensive overall view of Design Controls. The two courses are intended to be complimentary.
Does the course also cover ISO 13485-2003 or ISO 14971:2007 / EN ISO 14971-2012?
The course does discuss the relationship between relevant parts of the ISO 13485-2003 and FDA's 21 cfr part 820 regulation. After a comparison is established, the course materials follow FDA's 21 cfr part 820.30 references. Since the ISO 13485:2007 is not a free standard, it is not possible to distribute it with the course material.
The course also applies concepts consistent with ISO 14971:2007 as well as EN ISO 14971:2012. Since the ISO 14971:2007 and EN ISO 14971:2012 standards are not free, it is not possible to distribute it with the course material.
What materials come with the course?
A course notebook is provided that contains the slides that are presented, publicly available reference materials from FDA and other entities, class exercises, and example documents and procedures.
Are there particular types of medical devices emphasized?
No. A wide variety of medical device types are affected by the regulation, thus a broad view is presented.
Are any other topics covered outside of Design Validation, Verification, and Risk Analysis?
To the extent that other Design Control topics touch Design, Validation, Verification, and Risk Analysis, they will be discussed. Process Validation is discussed to the extent it can be contrasted with Design Validation.