Understanding the FDA's Proposal to Align QSR with ISO 13485 virtual, sheridan

OVERVIEW
The United States Food and Drug Administration (FDA) plays a crucial role in regulating medical devices to ensure their safety and effectiveness. In an effort to harmonize its regulatory framework with international standards, the FDA has proposed aligning its Quality System Regulations (QSR) with ISO 13485. This training will provide an overview of this proposal, highlighting its significance, potential benefits, and implications for the medical device industry.

This training offers an overview of the proposal, emphasizing the importance of ISO 13485, the present QSR framework, the suggested changes, and the possible benefits and difficulties associated with the alignment.

WHY SHOULD YOU ATTEND?
This training will provide you with the latest information on the proposed alignment between QSR and ISO 13485. By attending, you can stay up to date with regulatory changes that may affect your organization’s compliance requirements.
By attending this training, you can gain a comprehensive understanding of the proposed changes, timelines, and implementation plans, enabling you to proactively prepare for the transition.

LEARNING OBJECTIVES
nderstanding ISO 13485
Familiarity with FDA’s Quality System Regulations (QSR)
Knowledge of the FDA’s Proposal
Benefits of Alignment
Timeline and Implementation Plans

WHO WILL BENEFIT?
Regulatory Affairs Managers/Professionals:
Quality Assurance/Quality Control Managers/Professionals
Compliance Officers/ Managers
Manufacturing Managers/ Engineers
Research and Development (R&D) Managers/ Engineers
Auditors and Inspectors
Consultants and Advisors
Executives and Decision Makers

About speaker
Meredith Crabtree has over 25 years of experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Devices, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree, and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.