Introduction to US FDA Quality System Regulation (QSR) 21 CFR 820 - Online Live Training

The US FDA Quality System Regulation (QSR) is a set of regulations that outline the requirements for quality management systems (QMS) for medical devices.

The QSR is designed to help ensure that medical devices are designed, manufactured, and distributed in a safe and effective manner.

The QSR applies to all medical device manufacturers who intend to commercially distribute their products in the United States.

In the training, we'll also talk on the new QMSR - Quality Management System Regulation - which is the combined QSR and ISO-13485.

Training content:

• Introduction to US FDA QSR and its purpose
• Requirements of QSR – chapter by chapter
• Implementation of the QSR
• Looking ahead to the QMSR (combined ISO-13485 and QSR)

The training includes examples from the industry of how companies have implemented successfully the US FDA QSR

Duration: 3 hours

Audience: All medical device employees - Quality, Design, Manufacturing Associates, Engineers and Managers

About the trainer:

Helit Dovrin - Executive Consultant, Coach, Auditor and Lecturer worked for more than 25 years as Quality and Regulatory Senior Leader at the world leading medical device companies such as: Philips Healthcare, GE Healthcare, Align Technology and Biosense Webster part of Johnson & Johnson.

Helit gained experience & expertise in all areas of the Quality Management System and Regulatory Affairs including FDA & Notified Body Inspection Management, ISO-13485, EUMDR & MDSAP Compliance Audits, and Quality & Safety escalations.