AAMI Virtual Training courses
streaming live in Western European Time (WET).
Brought to you in partnership with:
Dates: 12-14, April, 2021 from 8:00 a.m. to 5:00 p.m. WET
This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.
Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.
This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding for developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues. Examples of design control tools, templates, and practices, in use by medical device companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, and industry consultants.
Dates: 19-23 April, 2021 from 8:00 a.m. to 5:00 p.m. WET
This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and ANSI/AAMI/ISO 13485:2016.
Dates: 13-15, September, 2021 from 8:00 a.m. to 5:00 p.m. WET
This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.
Meet your instructors:
Founder, GMP Advisory Services; Co-founder, CQT Solutions
Seb Clerkin is the founder of GMP Advisory Services, cofounder of CQT Solutions and a faculty member of the Association for the Advancement of Medical Instrumentation (AAMI). He currently provides quality system and regulatory consultancy to multiple clients within the Medical Device sector. He has an excellent track record in providing consultancy, training and auditing. His main expertise is in the areas of Regulations, Quality Management systems, Design Controls, Software and Process Validation. He is a IRCA certified lead auditor and provides auditing services to multiple clients. He has published articles in peer-reviewed journals on topics such as cleaning validation. He has a PhD from the University of Bristol, which involved studying the toxicological and biological effects of prosthetic implants, and is a member of AAMI and RAPS.
Owner & Founder, G&C Creations, LDT
Gerald (Ger) Manleyis a medical device professional with 20 years’ industry experience. Ger foundedG&C Creations ltd in 2004 and to complement the consultancy division of the business, added contract technical services in 2009. G&C Creations isbased out of Ireland andprovidesconsultancy services across Europe and North America. 16 of the 20 years’ experience are in the medical device fieldworking for a host of different companieswith considerable marketshare in the diagnostics, instruments, consumables, packaging andorthopedicssector. Gerhas extensive experience in New product introduction, technical transfers,product launches, process improvement, Lean, end to end supply chain and outsourced manufacturing. Hehas worked and consulted in all aspect of the medical device field and provides extensive consultancy on validation, design controls and all aspects of Quality systems. National Cert. Electronics Engineering-Tralee Institute of technology Ireland.National Diploma Mechanical and Electronic engineering-Tralee Institute of technology Ireland.Bachelor of Engineering Hons Mechanical / Production Engineering -University of Limerick Ireland.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email email@example.com.