Design Control Training for Medical Devices: Requirements and Best Practices
Available as a virtual instructor-led seminar.Overview
Fortunately, Alan Golden Principal at Design Quality Consultants, LLC with over 30 years’ experience working in the medical device industry will focus on introducing the attendees to the regulatory requirements stipulated under the US Medical Device Quality Systems Regulation. Each of the seven key elements of Design Control compliance will be briefly reviewed. In addition, specific GMP requirements, submission dossier preparation throughout the Design Control lifecycle and submission strategy will be discussed.
This Design Control course is US-focused. The participants will gain a fundamental understanding of how medical devices are regulated in the US: the main legal basis, FFDCA (21 U.S.C. 301) and the specific Medical Device Quality Systems Regulation, and the comparison/contrast of the GMP requirements imposed on the medical devices and pharmaceutical products in the US. In addition, the partipants will be introduced to a brief overview of relevant global regulatory framework including the EU MDR 2017 and the latest ISO standards (ISO 13485:2016).Who Will Benefit
This course will be most valuable to Medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers.
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.Agenda for the Seminar
Scope and Responsibilities
Design and Development Planning
Test Method, Process, and Software Validation
Design Transfer and Process Validation
Design History File
Final Comments and Questions
Upon completion of this course, participants will be able to:
World Compliance Seminars is Virtual Instructor-Led Training (WCS) is a real-time internet-based learning experience where the instructor and learners are in separate locations. WCS technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.Faculty Alan Golden
Principal at Design Quality Consultants
Wilmette, Illinois, United States
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.