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Site language : English - Français
Ref : 29519
Event :Creating a Risk-based Supplier Management program

Date :Wednesday April 24th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.

Objectives

This webinar will provide valuable assistance in:

  • Developing or updating your supplier control system to one based on risk
  • Complying with ever more stringent expectation of ISO 13485 auditors related to suppliers
  • Understand the special requirements related to contract manufacturers, distributors, and other critical suppliers
  • Determine different ways to assess suppliers based upon risk
  • Learn the importance of developing solid contractual agreements with key suppliers
  • Understand the importance of supplier quality and its relevance to ISO 13485 and FDA’s quality system requirements

Program

  • The types of suppliers that must be qualified according to the FDA and ISO 13485
  • Explanation, and use of the Global harmonization Task Force s(GHTF) and NBOC supplier guidance documents that you could be audited to
  • How to create or bring your supplier program into compliance with the these guidance documents
  • Definition of and requirements for Critical suppliers
  • Defining and controlling supplier risk and why this benefits you
  • Supplier qualification and control, best practices
  •  

Speakers

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.

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

Creating a Risk-based Supplier Management program Management
risk-based supplier control, supplier risk management, control of outsourced processes, supplier audits, ghtf, fda requirements for supplier control, iso 13485 requirements
Professionals, Quality Management Regulatory Affairs Supply-chain Management Supplier engineering Purchasing Management Supplier auditing
10 -- --
English

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