FDAnews Announces: Selecting and Managing Device Suppliers: Proven Techniques to Comply With FDA QSR and ISO 13485 Requirements, Webinar, Dec. 18, 2014

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Poorly designed and executed supplier audits are costing devicemakers millions and run the risk of 483s and warning letters. With compliance pro Jeff Kasoff as a guide, webinar attendees will master developing a bulletproof supplier controls program that assures quality products and flawless inspections.

Selecting and Managing Device Suppliers:
Proven Techniques to Comply With FDA QSR and ISO 13485 Requirements
**FDAnews Webinar**
Dec. 18, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/SelectingAndManagingDeviceSuppliers

Poorly designed and executed supplier audits are costing devicemakers millions and run the risk of 483s and warning letters. With dozens, hundreds or even thousands of suppliers to manage, devicemakers need a proven risk-based process that meets FDA and ISO requirements.

Devicemakers — patients, products and reputation rely on how supplier audits are conducted.

Fail to properly conduct supplier audits and lawsuits and liability are sure to follow, not to mention 483s and warning letters.

Looking for a proven solution that can reduce the number of audits conducted? Or how about not having to audit some suppliers ever again?

With compliance pro Jeff Kasoff as a guide, attendees will master developing a bulletproof supplier controls program that assures quality products and flawless inspections.

Jeff’s job is overseeing supplier qualification and assessment, including reviewing potential suppliers and evaluating their performance. He lives and breathes this stuff every day. And he’s on the front lines during FDA and ISO inspections.

In addition to a wealth of knowledge and best practices, attendees will receive these special bonuses:

  • Verbatim sections of a proven supplier agreement
  • Sample SCAR (Supplier Corrective Action Request) form that has been reviewed as part of many successful FDA inspections

Get set for a fast-paced 90-minute learning experience. Mr. Kasoff plans to cover a lot of ground:

  • Latest interpretation of QSR and ISO 13485 requirements for supplier selection and assessment by the FDA and EU investigators
  • How to sign on and qualify new suppliers cost-effectively
  • Innovative, economical assessment techniques for current suppliers — even when they number in the thousands
  • What to do when a supplier fails. How to use SCAR forms and explain them to investigators during audits
  • Minimum documentation for supplier qualification, assessment, and related corrective action
  • And much more

FDA and EU inspections are turning up countless supplier controls violations. Why risk a Form 483, warning letter or lawsuit? A cost-effective supplier controls program assures quality products and safe patients. Besides, it’s just good business

Meet the Presenter:
Jeff Kasoff, RAC, CQM, is Director-Quality at Medivators, a leading maker of endoscopy consumables and instrumentation. He previously served as Director of Regulatory Affairs at Life-Tech Inc., where he introduced and implemented a supplier management system. Prior to that, as Optex Biomedical’s first full-time employee, he initiated that devicemaker’s regulatory policies and procedures and prepared its submissions.

Who Will Benefit:

  • Supplier management professionals
  • Supply chain professionals
  • QA/QC personnel
  • Manufacturing directors and supervisors
  • Regulatory/legislative affairs professionals
  • Risk management specialists

Conference Details:
Selecting and Managing Device Suppliers:
Proven Techniques to Comply With FDA QSR and ISO 13485 Requirements
**FDAnews Webinar**
Dec. 18, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/SelectingAndManagingDeviceSuppliers

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online: http://www.fdanews.com/SelectingAndManagingDeviceSuppliers
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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