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Langue du site : Français - English
Réf : 29605
Evènement :A Bulletproof, Cost-Efficient Supplier Management Program

Date :Vendredi 14 Juin 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

Attend this webinar to learn the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. Also attendees will learn QSR and ISO requirements for supplier assessment and the application of a risk-based process resulting in a customized supplier management system.

Objectives

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them – try explaining that to your supply chain management!

Program

Supplier Selection

  • Review of FDA and ISO requirements
  • Types of suppliers that must be qualified
  • Defining critical suppliers
  • Classification of suppliers
  • Outsourced processes
  • The Quality Agreement
  • Recommended Practices

Supplier Assessment

  • Review of FDA and ISO requirements
  • Recommended Practices
  • How to avoid “Death by Supplier Audit”
  • Documentation requirements

Speakers

 
Jeff Kasoff

Jeff Kasoff
Director of Quality, Medivators

Jeff Kasoff, RAC, CMQ/OE, LBB, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.

 
 

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

A Bulletproof, Cost-Efficient Supplier Management Program Management - Médecine interne
supplier evaluation and assessment, medical device quality requirements, medical device supplier evaluation, medical device supplier, quality system regulation, iso 13485 requirements, medical device compliance, fda medical device requirements
Professionnels, Supply chain management Buyers Purchasing management CAPA Coordinators Regulatory management QA management Executive management Internal auditors
10 -- --
English

Divers

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