6 Hour Virtual Seminar: A Bulletproof, Cost-Efficient Supplier Management Program

Jeff Kasoff

Starting at

$1099


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Description:

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 and guidance documents, especially for outsourced processes such as contract manufacturing, sterilization and testing, and also 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 folks!

This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. The QSR/ISO requirements for supplier assessment will be defined as well. Attention will be paid to inclusion of risk management across both supplier qualification and assessment, implementation of which will allow your company to devote only value-added resources to these efforts. Also covered will be discussion of supplier nonconformance, including how and when to issue the dreaded Supplier Corrective Action Request.

Areas Covered in the seminar:

  Supplier Selection

  • Review of FDA and ISO requirements
  • Types of suppliers that must be qualified
  • Defining critical suppliers
  • Outsourced processes
  • Recommended Practices
  • Documentation requirements
  • Use of Risk Assessment
  • The Quality Agreement
  • Common Pitfalls

 Supplier Assessment

  • Review of FDA and ISO requirements
  • Recommended Practices
  • Documentation requirements
  • Use of Risk Assessment
  • Common Pitfalls

Supplier Nonconformance

Supplier Corrective Action Requests

  • Pre-notification?
  • Best Practices for Issuance
  • Followup
  • Evaluation/Acceptance of Supplier Response
  • Tracking effectiveness

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 

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Jeff Kasoff,

Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. 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.


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