UL is pleased to invite you to a one day training program on “ Complying with FDA’s Medical Devices 21 CFR 820 Quality System Regulation: An Overview”
Medical device manufacturers who intend to market their products in the USA are required to comply with the regulations set forth in the 21 CFR 820: Quality System Regulation. The scope of FDA’s Quality Systems Regulation (QSR) is huge – more than 500 pages of rules and guidance – and non-compliance is not an option. There has been an upward trend in medical device companies receiving Warning Letters for deficient quality management programs, and several were threatened with removal of their products from the market.
Compliance with FDA’s Quality Systems approach is recognized globally as a pre-requisite not only for getting your product on the US market but – just as importantly – keeping it there. This 1 day QSR Overview walks you through the requirements of 21 CFR 820, discusses how FDA’s rules correlate with ISO standards and examines current FDA inspection and enforcement priorities.
Topics for this course include:
- Introduction to regulations
- FDA & regulatory strategies
- Requirements of Quality System Regulation 21 CFR 820
- Overview of Qualiy System Inspection
- QSIT approach against Subsystems
- FDA Inspection and results
- Overview of QSR
- FDA resources available
- Identify differences between FDA QSR and ISO 13485
- Overview of the QSIT inspection technique
- What to expect in an FDA inspection
- Arrival of inspector and credentials
- How reception should react
- Opening meeting
- Tour of facility
- Dos and Don’t’s of inspection
- Preparing for the inspection
- Document production
- “War Room”
- End of day recaps
Speaker : Linda M. Chatwin
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the regulatory maze required to bring products to market. She holds a Regulatory Affairs Certification and is an attorney in the U.S. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. Currently, she heads the North American Advisory Services group for UL, LLC, assisting clients with regulatory issues and challenges, including implementation of UDI processes. Ms. Chatwin travels worldwide to speak about changing market access issues.
One Day Seminar on Complying with FDA’s Medical Devices 21CFR 820 Quality System Regulation: An Overview
|Rs. 15,000.00/- + Service taxes
Venue : UL India Pvt Ltd.
Time : 9:00AM to 5:00PM
Contact Details : E: [email protected] M: +91 96638 40174 T: +91 80 41384434