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Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel

 
  February 03, 2011  
     
 


GlobalCompliancePanel, Online Training Webinar
2011-03-03


Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards.

Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.

Why you should attend: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered "approved." You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain "approved." You never have to pay a visit to your supplier if you have a great supplier control program in place.

Areas Covered In the Seminar:
  • How to qualify new suppliers in a cost efficient manner
  • How to assess current suppliers in a cost efficient manner
  • How to perform supplier-related corrective action
  • Minimum documentation requirements for supplier qualification, assessment, and related corrective action
Who will benefit: This webinar will provide valuable assistance to all regulated companies that are interested in implementing a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:
  • Purchasing management
  • Regulatory management
  • QA management
  • Consultants
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff has presented dozens of webinars in many areas dealing with regulatory compliance. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
 
Deadline for Abstracts: 2011-03-03
 
Registration: Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
E-mail: webinars@globalcompliancepanel.com
 
   
 
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