ComplianceOnline

Best Practices for Lean Supplier Management in Compliance with FDA and ISO 13485 Requirements

Instructor: Jeff Kasoff
Product ID: 700193
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2012

Training CD / USB Drive

$299.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance.

Why Should You Attend:

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!

This webinar will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well.

Areas Covered in the Webinar:

Supplier Selection

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

Supplier Assessment

  • Review of FDA and ISO requirements
  • Recommended Practices
  • Justification of Desktop Audits
  • Documentation requirements

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:

  • Supply chain management
  • Buyers
  • Purchasing management
  • CAPA Coordinators
  • Regulatory management
  • QA management
  • Executive management
  • Internal auditors
Instructor Profile:
Jeff Kasoff

Jeff Kasoff
Director of Quality, Medivators

Jeff Kasoff, RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Mr. Kasoff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For 13 years prior to that, he served as director of regulatory affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Mr. Kasoff 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. He received his Regulatory Affairs Certification in 1996.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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