In session one of our workshop series, we will dive into the critical aspect of Supplier Controls, specifically focusing on meeting the increasingly stringent requirements set by the US and European regulatory bodies. We will explore the essential procedures necessary to comply with the Quality System Regulation (QSR), ISO 13485, and the new European Medical Device Regulation (MDR). Additionally, we will go a step further and guide you in creating a comprehensive template for a Supplier Agreement.
During this workshop, we will provide you with a step-by-step approach to developing procedures that meet the stringent supplier control standards set by regulatory bodies in the US and Europe. Whether you are a quality assurance professional, regulatory affairs specialist, or part of a manufacturing team, this workshop is tailored to address your specific needs.
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Learn effective strategies for implementing supplier controls:
Identify key elements to consider when establishing a robust supplier control process.
Discover best practices for assessing supplier qualifications, capabilities, and performance.
Understand the importance of risk management and mitigation in supplier controls.
Develop a procedure that meets QSR, ISO 13485, and European MDR:
Follow a practical framework for creating a comprehensive supplier control procedure.
Gain insights into aligning your existing processes with the regulatory requirements.
Receive guidance on documentation and implementation to ensure compliance.
Session One is scheduled for Wednesday, September 20th, from 10:00 AM to 12:00 PM PST
Gabriele Boss Howard is a Regulatory Coach and Consultant with extensive experience in certification bodies, spanning over 30 years. With more than 25 years of assisting clients with certification needs and CE-marking, Gabriele specializes in on-site audits for medical devices regulated under FDA, EU, and Health Canada regulations.
Laura Guy, MS, RAC, brings more than 30 years of experience in regulated industries to her company, Regulatory Liaisons, LLC. As a provider of Regulatory and Quality System compliance services, Laura assists innovators and manufacturers of pharmaceutical (Rx and OTC), biologic, cosmetic, and medical device products, including IVDs. Her expertise lies in establishing Quality Management Systems that promote compliance with US FDA and international requirements.
both, Laura and Gabriele bring a wealth of knowledge and experience to their respective roles, providing invaluable assistance to organizations in the regulated industry.