Expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA is intended to discuss adequate purchasing control requirements.

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Medical Devices: Do's To Better Control Suppliers
The ‘What’ and ‘How’ to Do to Exercise Better Supplier Control
Presenter - Dr. David Lim
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Disclaimer
• do not represent and should not be
construed to represent the host or policy.
• are my own views, interpretation and
understanding of the relevant and
applicable information (laws, regulations,
standards, rules and/or guidances).
• may be most helpful and effective when
used in conjunction with your professional
judgment and discretion.
• are not intended to be all inclusive.
The
contents
of this
presenta
tion:

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Objectives | Agenda
 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

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suppliers-12-09-2014.html