Quality Systems

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

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. Course content 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 ISO standards development teams.

23rd of March 2020

Munich, Germany

7th of September 2020

Dublin, Ireland

5 day course

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Design Control Requirements – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485

Benefit from an intensive focus on design control requirements for the FDA’s 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.

23rd of March 2020

Munich, Germany

21st of September 2020

Dublin, Ireland

3 day course

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Process Validation Requirements and Industry Practice

Obtain practical tools and techniques for process validation requirements for the FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force.

28th of September 2020

Dublin, Ireland

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Integrating Risk Management into the Product Lifecycle: Quality and 13485

Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements. Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave. Learn how to apply risk management principles to various aspects of a quality system.

9th of March 2020

Dublin, Ireland

12th of October 2020

Dublin, Ireland

3 day course

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Corrective and Preventive Action Requirements and Industry Practice

Experience intensive coverage of the elements of the corrective and preventive action (CAPA) system. Learn the purpose of a CAPA system and its integration throughout a quality management system.

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Purchasing Controls and Supply Chain Management

Industry experts will help you understand effective implementation of supplier selection and controls. Training covers the key aspects of supplier controls, from planning for supplier assessment/ selection, to defining acceptance activities, to monitoring supplier performance. Each topic is presented from a practical perspective, with links to the requirements of the Quality System regulation, the ISO 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidance.

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