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.
Learning Objectives
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.
Course Description
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.
View Course Agenda
Past Participant's Comments
“Course addressed a variety of useful and interesting topics. Covered all aspects of design control. Interesting and challenging exercises.”
Andrew R., Scientific & Regulatory Affairs Manager, MLT Research Ltd
“This course was extremely thorough. Design controls are now completely understood. The course was extremely informative. The instructor knew the topic and passed on his knowledge. All things were presented in a professional and excellent manner. The course director is a wonderful teacher.”
Christine W., Design Drafter, EBI, LP
“Very comprehensive coverage of topic with thorough references. Examples were appropriate to demonstrate the use of the tools.”
Jerry D., Research Scientist-Engineer, Pfizer
“The course was helpful both in validating things I learned from experience and pointing out where I made errors.”
Ralph H., Principal Engineer/Project Engineer, Analogic Corp.
“The course director was very knowledgeable of the design control process. He answered all my questions thoroughly.”
Angela W. , Sr. Product Development Engineer, Surgical Specialties
“Excellent course. Small number of students was very helpful in engaging in discussion, etc.”
Andrew B., Senior Regional Auditor, Pfizer U. K.
“I came into the course wondering how I could link design control concepts to QC testing of reagents in a diagnostic test that is being developed in my company. I feel that the course material and the way in which it was taught definitely helped me understand how I can get my job done more efficiently and what is really required in order to adequately assess various risk management issues as they relate to the above mentioned diagnostic test.”
Thomas V., Product Development Scientist III
“Good overview of device design control with a great range of topics addressed, including an impressive overview of CFR 820.30 and ISO 13485:2003!”
Martin P., Sr. Scientist, Pfizer
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