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    SUPPLIER AGREEMENTS, QUALITY AGREEMENTS AND OTHER 2016 - Establish and Maintain an Effective Supplier Qualification Program - By Compliance Global Inc

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    Website https://complianceglobal.us/product/700451/DavidRDills/effective-supplier-qualification-program/1 | Want to Edit it Edit Freely

    Category Education; E-Learning

    Deadline: July 14, 2016 | Date: July 14, 2016

    Venue/Country: online webinar, U.S.A

    Updated: 2016-06-24 14:15:53 (GMT+9)

    Call For Papers - CFP

    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

    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 document and the assessment of supplier capabilities

    Who Will Benefit:

    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

    For more information, please visit : https://complianceglobal.us/product/700451/DavidRDills/effective-supplier-qualification-program/1

    Email: supportatcomplianceglobal.us

    Toll Free: +1-844-746-4244

    Tel: +1-516-900-5515

    Level:

    Intermediate

    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. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives.

    Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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