Gabriele Howard’s Contact Form
Welcome to the HOW SERIES Hands-On Workshops!
How to Meet the More Stringent Supplier Controls for the US and Europe
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.
starts on
Tuesday
January, 14th
at 10:00 AM PST
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.
Sign up and you will receive invitations to our next workshop!
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.
Speaker Line-up
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.
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.
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.
Laura, Kelvin and Gabriele bring a wealth of knowledge and experience to their respective roles, providing invaluable assistance to organizations in the regulated industry.