RECORDED SEMINARS

Recorded Seminar

Supplier Management in FDA-Regulated Industry

timelapse Day followed by Breakfast & Lunch
with 10-15 mins of Q and A

Note:

Recorded Seminar can be played unlimited times
Along with recorded seminar, copy of presentation slides will be shared

Speaker/Presenter

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

Consultant

Short Abstract

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 significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This seminar 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. Also prominently covered will be supplier nonconformances: issuance, followup, and acceptance.


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Program Agenda

08:30 AM – 09:00 AM Breakfast + Introduction
09:00 AM - 10:00 AM Supplier Qualification/Selection
  • Review of FDA requirements
  • Review of ISO requirements
  • Types of suppliers that must be qualified
  • Defining critical suppliers
  • Outsourced processes
  • Case Study: A Hypothetical Supplier Selection
  • Recommended Practices
  • Use of Risk Assessment
  • The Quality Agreement
  • Common Pitfalls
10:00 AM - 10:10 AM Tea/Coffee Break
10:10 AM - 11:05 AM Supplier Assessment
  • Review of FDA requirements
  • Review of ISO requirements
  • Case Study: A Hypothetical Supplier Assessment
  • Recommended Practices
  • Use of Risk Assessment
  • Common Pitfalls
11:05 AM - 12:00 PM Types of Supplier Nonconformances
  • Best Practices for Handling
  • Best Practices for Notification
  • Trending
  • Evaluation of Supplier Response
  • Tracking effectiveness
12:00 PM - 12:30 PM Supplier Corrective Action Requests
  • Prenotification?
  • Best Practices for Issuance
  • Followup
  • Evaluation/Acceptance of Supplier Response
  • Tracking effectiveness
12:30PM - 01:00PM Q&A - Conclusion
01:00 PM - 02:00 PM Lunch

Registration Information

  • Registration Fee : USD $299
  • For assistance on registration, please send an email to marketing@biopractice.com or
    Please call: Ph - 1-646-216-8860
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