Introduction to US FDA Quality System Regulation (QSR) 21 CFR 820 - Online Live Training
Sun, 22 Sept
|Virtual Event
Master FDA Compliance: Join our 21 CFR 820 Training! Explore the essentials of quality management in medical devices, ensuring seamless adherence to FDA regulations. Get to know QMSR - the new regulation effective Feb 2026. Elevate your expertise and advance your career in a comprehensive session!
Time & Location
22 Sept 2024, 9:30 am – 1:00 pm GMT+3
Virtual Event
About the event
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.
In the training, I will emphasize the new QMSR (Quality Management System Regulation) Requirements which will be effective on February 2026.
Training content:
- Introduction to US FDA QSR and its purpose
- Requirements of QSR – chapter by chapter
- Introduction to QMSR - structure and requirements
- Implementation of the regulations
The training includes examples from the industry of how companies have implemented successfully the US FDA Quality System Regulations
Duration: 3.5 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.