Regulatory Authorities place the responsibility of the Quality Management System firmly onto the shoulders of a medical device firm’s management team; however, many executives do not have an appreciation or awareness of these requirements. This course presents an overview of the QMS, with a focus on management’s roles and responsibilities to demonstrate an active commitment [...]
While it may not always be the favorite part of a technician’s job, everyone in healthcare technology management (HTM) today has the critical responsibility to enter complete and accurate data into their CMMS. This data is needed to meet regulatory requirements, make smart staffing decisions, ensure the equipment is safe and reliable, protect the hospital [...]
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 [...]
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 utilize ANSI/AAMI/ISO 13485. Join us to gain understanding of best practices of auditing quality managements systems as defined in ANSI/ISO [...]
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 subject has been called many names, such as Measurement System Analysis (MSA) and Gauge Repeatability & Reproducibility (GR&R). There is [...]
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 System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and / or validating actions; [...]
Today the news is inundated with stories about cybersecurity compromised businesses, public services, and government operations. Among those we often hear as being compromised are hospitals and healthcare-related organizations. When compromises to healthcare organizations do occur, they have frequently shut down a department’s or an entire organization’s operations so that their ability to deliver healthcare [...]
Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more. Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how [...]
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 [...]
This 3-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 [...]