Establish and Maintain an Effective Supplier Qualification Program
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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/purchasing controls related proof, i.e., the documentation. Learn why and how to establish and maintain the requirements, including 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 quality requirements. Identify the key elements of a robust, sustainable and successful supplier qualification program. 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.
Areas Covered in the Session:
Who Will Benefit:
- 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
- Selection and qualification of suppliers by audits and performance analysis are part of your quality system
- Approved Supplier List and areas to be targeted during the assessment or evaluation
- Learn the elements of the SOP and the assessment of supplier capabilities
- All levels of Management and personnel from all departments who desire to learn how this process works
- QA/QC/Compliance/Regulatory Affairs
- Engineering/R&D/Technical Services
David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry.
He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM's/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations.
Mr. Dills most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.
He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products.
David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.
He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk.
He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.