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US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485
Understanding ISO 13485
- Overview of ISO 13485:2016 standard
- Key requirements of ISO 13485
- Importance of ISO 13485 in the medical device industry
Overview of FDA's Quality System Regulations (QSR)
- Introduction to the FDA's regulatory framework for medical devices
- Key components of the QSR
- Current differences between QSR and ISO 13485
FDA's Proposal to Align QSR with ISO 13485
- Background and rationale for the proposed alignment
- Key changes and updates proposed by the FDA.
- Implications for medical device manufacturers
Benefits of Aligning QSR with ISO 13485
- Enhanced global harmonization and regulatory consistency.
- Streamlined compliance efforts for companies operating in multiple markets.
- Increased competitiveness and market access for US medical device manufacturers
Challenges and Considerations
- Impact on existing medical device manufacturers
- Training and educational requirements for implementation
- Potential challenges in transitioning to the new regulations
Timeline and Implementation Plans
- FDA's proposed timeline for the alignment process
- Key milestones and deadlines for compliance
- Support and resources available to assist companies in the transition.
Overview of the webinar
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.
Who should attend?
- Quality Assurance Managers
- Regulatory Affairs Specialists
- Quality Control Inspectors
- Compliance Officers
- Quality Systems Managers
- Medical Device Engineers
- Auditors (Internal and External)
- R&D Managers in Medical Device Companies
- Manufacturing Managers
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. It will provide insights into the similarities and differences between QSR and ISO 13485, helping you identify areas where your current compliance efforts can be aligned and streamlined.
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.
Faculty - Miss.Meredith Crabtree
Meredith Crabtree has over 25 years’ experience in regulated industries ranging from Pharma, Medical Device, Biologics, Laboratory testing, Cosmetics, and Supplements. She has worked in both manufacturing and distribution as well as Human Health and Animal Health. Meredith currently 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.