Important info about the event
Here are all the important info about Understanding the FDA's Proposal to Align QSR with ISO 13485.
| Category: | Events |
| Event Category: | Webinar |
| Event Type: | Education and Training |
| Starting Date: | Nov 21, 2023 (Tue) |
| Last Date: | Nov 21, 2023 (Tue) |
| Event Status: | Expired |
| Organized By: | Skillpreceptor |
| Venue: | online |
| Event Add: | sheridan |
| City: | Sheridan |
| Country: | United States |
| Event link: | https://skillpreceptor.com/training/362/understanding-fdas-proposal-to-align-qsr-with-iso-13485 |
Understanding the FDA's Proposal to Align QSR with ISO 13485
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.
The FDA has proposed the alignment of its Quality System Regulations (QSR) with ISO 13485, a global standard for quality management systems in the medical device industry. This standard provides a foundation for organizations to create and maintain quality systems that comply with regulatory and customer demands. The proposed alignment aims to strengthen regulatory uniformity and streamline worldwide market entry for medical device manufacturers.
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.
LEARNING OBJECTIVES
- Understanding ISO 13485: Participants will gain an in-depth understanding of the ISO 13485 standard, its key requirements, and its significance in the medical device industry. This objective aims to provide a solid foundation for comprehending the proposed alignment.
- Familiarity with FDA's Quality System Regulations (QSR): Participants will become familiar with the FDA's current regulatory framework for medical devices, including the key components and requirements of the QSR. This objective aims to highlight the existing differences between QSR and ISO 13485.
- Knowledge of the FDA's Proposal: Participants will gain knowledge about the FDA's formal proposal to align QSR with ISO 13485. They will understand the background, rationale, and key changes proposed by the FDA. This objective aims to provide insights into the potential impact of the alignment on medical device manufacturers.
AREAS COVERED
- Understanding ISO 13485
- Overview of FDA's Quality System Regulations (QSR)
- FDA's Proposal to Align QSR with ISO 13485
- Benefits of Aligning QSR with ISO 13485Challenges and Considerations
- 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.
FAQs about Event
Let's now talk about some of the most frequently asked questions about Event. These questions are based on need of users.
What is the starting date of the event?
Event will start from Nov 21, 2023.
What is the last date of the event?
Event will end on Nov 21, 2023.
What is the address of the event?
Sheridan.
What is the event website?
You can check out more info about the event at https://skillpreceptor.com/training/362/understanding-fdas-proposal-to-align-qsr-with-iso-13485.
Event organizing country?
United States.
City Name of the event organizer?
Sheridan.
What is the area pin code of the event?
Area pin code for the event is 82801 .
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