AAMI Event – Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – August 22, 2022
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 [...]
AAMI Virtual Event – Lead Auditor for Management Systems & Processes – Principles & Practices – August 4-5, 2022
A Lead Auditor is responsible for leading an audit team in an organization—preparing the audit plan, delivering meetings and submitting audit reports. AAMI’s 2-day Lead Auditor course teaches participants the requirements of and how to [...]
AAMI Event: Test Method Validation Workshop – July 19-20, 2022
Test Method Validation (TMV) is not only an FDA regulatory requirement, it is key to quality and financial success for a firm. How do you know that you have quality if you cannot measure? This [...]
AAMI Virtual Event – Corrective & Preventive Action Requirement & Industry Practice – June 27-28, 2022
This 2-day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management [...]