Overview:

FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.

FDA has the right to see certain elements of your supplier qualification/supplier risk management/purchasing controls related proof, i.e., the documentation.

Why Should You Attend:

Learn why and how to establish and maintain the requirements, including supplier quality requirements, that must be met by suppliers, contractors, and consultants. Understand why you need to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. Document this evaluation or assessment and define the type and extent of control to be exercised based on the evaluation results. You need to establish and maintain data that clearly describe or reference the specified requirements, including supplier agreements.

Areas Covered in this Webinar:

The process is critical for device manufacturers to effectively evaluate and select suppliers and subsequently implement agreements ensuring consistent material quality and/or services provided. The process defines the elements associated with a supplier's processes that are critical to quality. It also defines how conformance to manufacturer requirements will be monitored and verified.

Learning Objectives:

Learn the pre-selection, selection and assessment process through the use of various tools
Methods, techniques and strategies that work and are proven with supplier relations and qualification
Learn how to apply risk-based approaches and why and how to "rank" suppliers
Supplier Agreements, Quality Agreements and other documentation including Audits/Assessments
What to measure and how to measure supplier performance and assign classifications or levels
All levels of Management and Personnel from all departments who desire to learn how this process works
QA/QC/Compliance/Regulatory Affairs Personnel
Engineering/R&D/Technical Services Personnel
Purchasing/Procurement/Sourcing Personnel
Consultants
Operations/Manufacturing/Validation Professionals

Speaker Profile:

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape.

Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S.

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