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 820.30. The course also provides context for 820.30 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.
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.