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AAMI – Quality System 21 CFR 820 and ANSI/AAMI/ISO 13485 – September 20-24, 2021

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 [...]

2021-09-07T21:17:53+00:00September 7th, 2021|

AAMI – Process Validation Requirements & Industry Practices – August 10-12, 2021

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 [...]

2021-07-24T20:31:35+00:00July 24th, 2021|

AAMI Virtual Training – Integrating Risk Management into the Product Lifecycle – June 28-30, 2021

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 [...]

2021-06-14T19:25:29+00:00June 14th, 2021|

AAMI Virtual Training – Process Validation Requirements & Industry Practices – April 14-16, 2021

Process Validation Requirements & Industry Practices is a 3-day, virtual training that will provide attendees with practical tools and techniques for process validation requirements to meet FDA’s Quality System Regulation, the ISO 13485:2016 Standard, and recognized Process Validation Guidance from the Global Harmonization Task Force. The program will feature industry best practices and real-life process validation examples [...]

2021-04-13T19:59:52+00:00April 13th, 2021|

AAMI Virtual Event – Medical Device Software Validation – March 31 – April 2, 2021

During this 3-day training, learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in all the relevant regulations, standards and guidance and help you understand how risk, cybersecurity, cloud computing and mobile apps impact the medical device software space.  It will also [...]

2021-03-30T22:36:24+00:00March 30th, 2021|

AAMI Virtual Course – Quality System 21 CFR 820 and ANSI/AAMI/ISO 13485 Navigating Regulatory Requirements – offered virtually March 22-24, 2021

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 [...]

2021-03-15T18:02:31+00:00March 15th, 2021|

AAMI Course – Quality System 21 CFR 820 and ANSI/AAMI/ISO 13485 – March 1-5, 2021

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 [...]

2021-02-26T14:57:04+00:00February 26th, 2021|

AAMI Course – Sampling Plans Workshop – February 25, 2021, February 26, 2021, and March 1, 2021 / 1:00 pm – 3:00 pm ET

Sampling a product or process and measuring a quality characteristic is an efficient way to make an inference about the quality of all products or the entire process. Simply put, if it is too expensive to measure everything, then you would be wise to sample and measure a subset. If you decide to sample, then [...]

2021-02-24T18:44:14+00:00February 24th, 2021|

AAMI Course – Integrating Risk Management into the Product Life Cycle – Offered Virtually February 17-19, 2021

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 [...]

2021-02-16T20:12:05+00:00February 16th, 2021|

AAMI Course (Offered Virtually) – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 – February 8-10, 2021

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. For more info:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000008FZqZ

2021-01-15T18:04:32+00:00January 15th, 2021|