Skip to main content

Listen

Read

Watch

Schedules

Programs

Events

Give

Account

Donation Heart Ribbon

ADVERTISEMENT | Become a sponsor today!

Supplier Management In FDA- And ISO-Regulated Industry

    THIS EVENT IS IN THE PAST!

  • WHEN Thursday, September 14, 2017 at 9 a.m. Friday, September 15, 2017 at 9 a.m.
  • WHERE DoubleTree by Hilton San Diego Downtown, 1646 Front St, San Diego, CA 92101
    Map | Website
  • AGES All ages
  • COST $1295 - $1495

Course "Supplier Management in FDA- and ISO-regulated Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. 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 in across both supplier qualification and assessment, implementation of which will allow your company to devote value-added resources to these efforts. Significant time will be spent on discussion of the topic of supplier nonconformance, including how and when to issue the dreaded Supplier Corrective Action Request. Your supplier nonconformance handling process must be nonconfrontational, or even better, collaborative. 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.

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 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!

Areas covered in the session:

Supplier Selection
Review of FDA requirements
Review of 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 requirements
Review of ISO requirements
Case Study: A Hypothetical Supplier Assessment
Recommended Practices
Documentation requirements
Use of Risk Assessment
Common Pitfalls
Supplier Nonconformance
Types of supplier nonconformances
Best Practices for Notification
Best Practices for Handling
Trending
Evaluation of Supplier Response
Tracking effectiveness
Supplier Corrective Action Requests
Pre-notification?
Best Practices for Issuance
Followup
Evaluation/Acceptance of Supplier Response
Tracking effectiveness
Workshop: Review of Supplier Responses: Acceptable or Unacceptable?

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

View the agenda here.

Speaker:
Jeff Kasoff
Director of Regulatory Affairs, Life-Tech, Inc

Dates and times of events are subject to change without notice. Always check the event organizer's website for the most updated schedule before attending.

Promotional photo of previous seminar. Courtesy of Global Compliance Panel

Above: Promotional photo of previous seminar. Courtesy of Global Compliance Panel

Categories

Related links

Submit a correction for this event

ADVERTISEMENT | Become a sponsor today!