Join us this fall for AAMI Virtual Training courses on 5 critical topics,
streaming live in Western European Time (WET).
Brought to you in partnership with:
Dates: 7–11 September, 2020 from 8:00 a.m. to 5:00 p.m. WET
This intensive 4.5-day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. 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, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices-Application of Risk Management to Medical Devices.
This is an updated version of our previous Quality System Requirements and Industry Practice course. Included are important developments in world-wide medical device regulations and revised standards, specifically 13485 and the International Medical Device Regulators Forum Medical Device Single Audit Program (MDSAP).
Dates: 21–23 September, 2020 from 8:00 a.m. to 5:00 p.m. WET
This intensive three-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. An optional exam is available online for 2 weeks following the end of the program.
Dates: 28–30 September, 2020 from 8:00 a.m. to 5:00 p.m. WET
This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Topics include planning, protocol development, validation execution, monitoring & control and re-validation to meet the FDA’s expectations and the industry’s best practices.
Dates: 12–14 October, 2020 from 8:00 a.m. to 5:00 p.m. WET
This comprehensive three-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the lifecycle of the product (design, manufacturing, post-production, 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 lifecycle, as well as the use of International Product Safety Standards during risk management activities.
Dates: 12–14 October, 2020 from 8:00 a.m. to 5:00 p.m. WET
This three-day workshop supplies attendees with practical tools and techniques for software validation for embedded device software, off-the-shelf software, and Quality System (non-device) software. It includes real-life software validation examples utilizing engineering and software quality "best practices." The workshop includes practical information on a variety of topics, such as writing useful and testable requirements, techniques for testing, and streamlining quality processes for development and validation efforts.
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.