Medical Devices: Do's To Better Control Suppliers

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Tue, Dec 09, 2014
Length
60 minutes
Product Description

The ‘What’ and ‘How’ to Do to Exercise Better Supplier Control

Device manufacturers are required to establish and maintain procedures to ensure all purchased or otherwise received products and services conform to their specified requirements. A significant number of product recalls (due to component failures) have resulted from a manufacturer’s failure to adequately establish and follow purchasing control and in particular, supplier control. There have been a number of FDA warning letters issued for violating purchasing control regulations. 

This conference by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA is intended to discuss adequate purchasing control requirements and to focus on suppliers to ensure that the firm’s purchasing control procedures are adequately established and maintained. In particular, you will understand what to do and how to do (“Do's”). If you already have purchasing control procedures, you can still join this conference to make sure your procedures contain all the necessary requirements for suppliers pursuant to applicable laws, regulations or standards. 

At the end of the conference, you will become familiar with the best practices for purchasing control including supplier requirements and control. In this 60-minute presentation, Dr. Lim will guide you through the details of “Do's” to better control suppliers. 

Training Objective:

  • Statutes and Regulations
  • Definitions for Key Terms
  • ISO 9000 and ISO 13485
  • Detailed Analysis of Regulatory Requirements for Purchasing Control and Acceptance
  • Supplier: Principles and Planning
  • Timing and Selection of Suppliers
  • How to Evaluate Suppliers
  • What and How to Implement Purchasing Control Requirements
  • What to Do and How to Prepare for FDA Inspection on Purchasing Control
  • Supplier Auditing: Decision Points
  • What Items or Processes of the Suppliers to Audit
  • How to Audit Suppliers
  • Various Audit Approaches
  • FDA Warning Letters based on 91 Cases for the Past 10 Years
  • Common Deficiency
  • How to Avoid 483s and Warning Letters
  • Best Practices: Speaker’s Suggestions and Recommendations

Who Should Attend

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Complainant Managers
  • Managers (RA, QA/QC, CA)
  • Consultants
  • Contractors and Subcontractors
  • Anyone interested in the topic

 

 

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.


Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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