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 Tuesday, January 14th, 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.
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Her knowledge covers a broad range of regulations, including the ISO 9000 series, ISO 13485, and various European Directives such as the Medical Devices Directive (MDD) and the Medical Device Regulation (MDR).
Gabriele’s areas of expertise encompass Quality Management Systems, Risk Management, EU Technical File Reviews, and Leadership Development. Her well-rounded skill set allows her to offer comprehensive support to clients seeking certification and compliance with regulatory requirements. Gabriele is known for her creative approach and unwavering drive to achieve success.
Gabriele is proud to collaborate with Kelvin Askew, a highly experienced consultant specializing in supplier controls for the US market. Kelvin brings extensive knowledge of regulatory requirements and best practices, enhancing our ability to ensure compliance, maintain quality, and strengthen our supply chain management processes.
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His expertise, combined with his strong project management skills and experience interacting with various stakeholders, enables us to share best practices in controlling critical suppliers to ensure our products meet the highest standards of safety and performance.
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.
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Laura’s services encompass a range of areas to support her clients. She conducts GXP auditing, delivers training programs, and provides mentoring to employees, all aimed at fostering regulatory and quality system compliance within organizations. For clients seeking regulatory submissions such as INDs, NDAs, IDEs, PMAs, and 510(k)s, Laura offers strategic guidance to develop practical and successful plans for introducing products into the marketplace. She ensures that these plans prioritize safety and effectiveness throughout the product’s lifespan.
Laura, Kelvin and Gabriele bring a wealth of knowledge and experience to their respective roles, providing invaluable assistance to organizations in the regulated industry.