Copyright © 2014 REGULATORY DOCTOR. All Rights Reserved. 1

Medical Devices: Do's To Better Control SuppliersThe ‘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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To see the complete presentation check the

below link:

http://www.audioeducator.com/pharma-biotech/medical-devices-better-control-

suppliers-12-09-2014.html