Quality In, Quality Out: Regulatory Drivers of Supplier Quality Management in the Medical Device Industry -- New Webinar Hosted by Xtalks
In this second of a four-part webinar series, the presenter will take a specific and deeper dive into the regulatory requirements for supplier management for the MedTech - medical devices and in-vitro diagnostics - industry.
TORONTO, July 26, 2018 (Newswire.com) - Join industry expert Phil Johnson, Senior Director of Quality and Compliance Services at IQVIA, for a live webinar on Wednesday, Aug. 15, 2018, at 10 a.m. EDT (3 p.m. BST/UK).
The supplier pyramid is more complex in MedTech than in the pharmaceutical arena, often with a multi-level supply chain providing parts that feed up into the finished device. It is the organization at the end of this chain (who is considered the legal manufacturer, or specification developer) that registers the resulting device and places the device on the market. It is also this organization that the regulators hold responsible for safety issues in the field. Therefore, it is critical that this organization is aware of and abides by all the applicable regulations.
A large part of the regulator's focus is identifying how legal manufacturers can effectively control their suppliers and sub-suppliers. This is particularly challenging as some sub-suppliers simultaneously produce other parts intended for general industrial use that are not intended to be part of a complex medical device and therefore do not adhere to the common medical device QMS requirements (i.e., ISO 13485:2016). More so, those same sub-suppliers may not want to take on the challenges associated with making a finished medical device or a medical device component, and they may decline to provide their products/materials to a demanding customer.
In the past, it has been common practice for virtual manufacturers, private label manufacturers (PLM) or own brand labelers (OBL) to take finished medical devices from contract manufacturers and then label them as their own brand, making use of the contract manufacturers' technical files/dossiers. Recent updates to the ISO13485:2016 standard and EU competent authorities (MHRA) have revised the responsibilities of the legal manufacturer to include not only quality assurance at the sub-contractor but complete oversight of the regulatory technical files/dossier. Within the medical device arena, the terms "PLM" and "OBL" will be withdrawn and replaced with "virtual manufacturer," which is more in alignment with the pharmaceutical industry term.
During this presentation, our featured speaker will look further into the revisions to ISO13485:2016 which increase the requirements for supplier management, especially the monitoring of suppliers. This standard further documents the need for manufacturers to take a "risk-based approach" in the selection, qualification, monitoring and re-evaluation of contract suppliers of both product and services. In addition, we will cover the specific needs, by country, of the Medical Devices Single Audit Program (MDSAP) and will discuss what to expect from an MDSAP audit in relation to supplier management.
An overview of 21 CFR Part 820 will be presented, providing guidance and industry views on how the FDA interprets purchasing controls for both legal manufacturers and their suppliers. We will also offer further analysis of the most common FDA enforcement actions (483, Warning Letters) and present the latest FDA statistics for 2018 YTD on the increasing number of product recalls for medical devices.
For more information or to register for this event, visit Quality In, Quality Out: Regulatory Drivers of Supplier Quality Management in the Medical Device Industry (Part 2 of 4).
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks, visit http://xtalks.com.
For information about hosting a webinar, visit http://xtalks.com/why-host-a-webinar/.
Contact:
Nima Rajan
Tel: +1 (416) 977-6555 ext 352
Email: nrajan@xtalks.com
Source: Xtalks
Related Media
