This 90-minute webinar 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.

Why Should You Attend:

The FDA has proposed aligning its Quality System Regulations (QSR) with ISO 13485, an international standard for quality management systems in the medical device industry. ISO 13485 provides a framework for organizations to establish and maintain quality systems that meet regulatory and customer requirements. The proposed alignment aims to enhance regulatory consistency and facilitate global market access for medical device manufacturers. This training provides an overview of the proposal, highlighting the significance of ISO 13485, the current QSR framework, the proposed changes, and the potential benefits and challenges associated with the alignment. It equips participants with the knowledge to understand the implications of the proposed alignment and prepares them for compliance with potential changes in the regulatory landscape. 

Course Outline: 

• 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.

• Benefits of Alignment: Participants will learn about the benefits associated with aligning QSR with ISO 13485. This objective aims to highlight the enhanced global harmonization, streamlined compliance efforts, and increased competitiveness for US medical device manufacturers.

• Challenges and Considerations: Participants will explore the potential challenges and considerations associated with the proposed alignment. This objective aims to provide a comprehensive understanding of the implications, including the impact on existing manufacturers, training requirements, and potential challenges in transitioning to the new regulations.

• Timeline and Implementation Plans: Participants will gain knowledge of the proposed timeline and implementation plans for the alignment process. This objective aims to help participants prepare for the transition and understand the key milestones and deadlines for compliance.

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

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