This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus will be placed on basic regulation and the FDA's supplemental guidelines.
Among the topics to be discussed are: context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control.
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 Design Control per the FDA's CFR 810.30. The course also provides context for 810.30 vs. the Design Control part of ISO 13485:2003.
Personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of the Design Control, 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 of the FDA's Design Control requirements.
Upon completion of this course, attendees will have an understanding of the framework for Design Control and recommendations to effectively meet the requirements of Design Control. Emphasis will be placed not only on regulatory aspects but on effective design strategy, which is very important to avoid spending unnecessary time and money on an ineffective design control process.
Through the use of interactive instruction, this course will cover the general context for design control, quality systems, standards, and recommended design control procedures. Special attention is given to implementation aspects of key parts of design control. Manufacturing transfer and general quality system topics will be covered as they relate to the design process. Several exercises will be completed by attendees to reinforce key concepts. Participants will receive extensive course notes that are designed to be used as reference material once the course is completed.
Frequently Asked Questions
Is the course different than the Design Validation, Verification, and Risk Analysis 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 ISO 13485-2003?
The course does discuss the relationship between 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 partly because the regulation and the corresponding guidance documents are publicly available without purchase.
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 Control?
A short but broad overview of key medical device regulations that relate in some way to Design Controls are presented in order to provide additional context for the course.