Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers

This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.

Recorded Version Only

(PPT + Recorded Streaming Link)

$249.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Oct-2019

CD or USB Drive Only

(PPT + Recorded Training File)

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
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Learning Objectives:
  • To learn why QA agreements are necessary and desirable.
  • To review which suppliers need QA agreements with.
  • To the contents of supplier Quality Assurance agreements.
Areas Covered in the Webinar:
  • The types of suppliers that should have QA Agreements to assure FDA and ISO 13485 compliance.
  • Explanation, and use of the Global harmonization Task Force s (GHTF) and NBOC supplier guidance documents to create QA agreements.
  • How to create supplier QA agreements and the best way to implement them.
  • Definition of and requirements for Critical suppliers.
  • Supplier agreements best practices.
Who Will Benefit:

This webinar will provide valuable assistance to all personnel in

  • Quality Management
  • Regulatory Affairs
  • Supply-chain Management
  • Supplier engineering
  • Purchasing Management
  • Supplier auditing
Instructor Profile:
Betty Lane Betty Lane

Founder and President, Be Quality Associates LLC

Betty Lane, has over 30 years experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.
Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the RAPS, Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.

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. FDATrainingAlert 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@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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