Quality In, Quality Out: Exploring Pharmaceutical and Medical Device Supplier Quality Management (Part 1 of 4)

In this presentation, the first in a 4-part webinar series examining supplier quality management for the pharmaceutical and medical device industries, the speaker will explore the business and regulatory drivers for this key quality and compliance and extended enterprise supply chain requirement need. In webinar #2 and #3, the regulatory requirements specific to the medical device and pharmaceutical industries will be explored in more detail. The final webinar in the series will examine technology options for managing a supplier quality management program within a centralized cloud-based network that supports all supplier-related procedures and processes.

In this first webinar, the speaker will look at the business and regulatory drivers that set the requirements for supplier quality management, identifying industry best practices and examples of the wrong way to address supplier quality management. IQVIA has worked with manufacturers around the globe over the years in assessing their needs for contracting suppliers, and has also worked with suppliers as they develop business and supply agreements to provide manufacturers with their products and services.

The business drivers for using contract suppliers are many, and it is critical to identify the positives and negatives and to properly assess the associated risks of contracting with 3^rd party suppliers. It is alarming to still see manufacturers begin receiving products and services from suppliers without conducting effective due diligence on the supplier and without securing a formal agreement. The manufacturers will often concentrate on the product suppliers, and ignore critical service providers (i.e., translation services, regulatory consultants, etc.) in the process. Early in this webinar, the different scenarios in which manufacturers rely on suppliers, as well as offer recommendations on how to proceed with the process of engaging with suppliers will be discussed.

One important element of the supplier quality management process is the need within an organization for all the relevant departments to work together as an efficient team. Quite often, the process can be doomed to fail due to conflicting interests and lack of coordination between all the required departments. The webinar will include real-world examples of how conflicting business needs at a manufacturer resulted in product recalls due to defective incoming supplier product.

The business drivers are important, but the regulatory needs will have to be identified as part of the assessment and qualification of suppliers. Statistics indicate that the majority of pharmaceutical and medical device recalls are due to defects at the supplier. In this webinar, the speaker will take a high-level look at the regulatory needs for supplier management and how ever-changing requirements are putting more pressure on manufacturers to ensure adequate supplier/purchasing controls are in place.

Speaker

Phil Johnson, Senior Director, Quality and Compliance Services, IQVIA

Phil is an experienced regulatory and quality based professional who has worked in the medical device, in-vitro diagnostic (IVD) and pharmaceutical industries for over twenty-five years. His core expertise is in the quality requirements for medical devices, diagnostics and pharmaceuticals. This has included the writing, implementation and maintenance of quality systems, auditing of external suppliers and manufacturing/distribution sites and due diligence auditing.

Phil has worked on FDA remediation programs in response to warning letters and import bans, providing strategic consulting to companies. He has had several long-term consulting placements within medical device, IVD manufacturing and distribution sites and corporate offices. He supports companies by providing complete business, regulatory and quality support for global market entry requirements, including the setting up of logistics and distribution networks and the license requirements for these operations.

In his industry roles prior to joining IQVIA he was very involved in supplier management, in both the manufacturer role of evaluating and qualifying suppliers, and also in the supplier role providing services and products to pharmaceutical clients. In his consulting role with IQVIA he has run many supplier management projects, providing support from corporate clients to virtual organizations and start-ups. This has covered the whole breadth of services from supplier selection, evaluation, qualification, monitoring and follow up auditing, covering both business and quality functions. This has given him a good oversight of good client processes and equally poor systems that have needed extensive remediation.

Prior to joining IQVIA in 2002, he was the founder and director of a UK central laboratory providing worldwide IVD services to the pharmaceutical industry.

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