Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner

7 years ago Posted By : User Ref No: WURUR11578 0
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  • TypeWebinar
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  • Location San Diego, California, United States
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  • Date 01-05-2017
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner, San Diego, California, United States
Webinar Title
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
Event Type
Webinar
Webinar Date
01-05-2017
Location
San Diego, California, United States
Organization Name / Organize By
Compliance4All
Organizing/Related Departments
Healthcare
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Business Development

Medical/Healthcare/Hospital

Location
San Diego, California, United States

Overview:

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly 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 procedures in place that describe 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 may never have to pay a visit to your supplier if you have a good supplier control program in place.

Why should you Attend:

Supplier qualification and assessment is required according to both QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Organizations can, however, 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. It will also provide cost efficient and equally compliant options for many of the most common practices in supplier management programs.
Areas Covered in the Session:

  • QSR and ISO requirements for supplier selection
  • QSR and ISO requirements for supplier assessment
  • Recommended processes for new supplier qualification in a cost efficient manner
  • Recommended processes for current supplier assessment in a cost efficient manner
  • Supplier-related corrective action: Practices, Documentation, and Follow-up
  • Implementation of a lean system 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:

  • Supply chain management
  • Purchasing management
  • Regulatory management
  • QA management
  • Executive Management

 

Speaker Profile

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.

Others Details

For more details and updates please visit webinar website

Registration Fees
Available
Registration Fees Details
One Dial-in One Attendee Price: $150.00 For more details and updates please visit webinar website
Registration Ways
Email
Phone
Address/Venue
  Netzealous LLC DBA - Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: [email protected]  Pin/Zip Code : 94539
Official Email ID
Contact
Event Manager

Netzealous LLC DBA - Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: [email protected]

[email protected]

     8004479407
   Fax No: 302-288-6884