đ¸Cash Payment No Advance Call Girls Kanpur 𧿠9332606886 𧿠High Class Call Gir...
Â
Medical Devices: Do's To Better Control Suppliers
1. Copyright Š 2014 REGULATORY DOCTOR. All Rights Reserved. 1
Medical Devices: Do's To Better Control Suppliers
The âWhatâ and âHowâ to Do to Exercise Better Supplier Control
Presenter - Dr. David Lim
Follow us :
2. Copyright Š 2014 REGULATORY DOCTOR. All Rights Reserved. 2
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:
3. Copyright Š 2014 REGULATORY DOCTOR. All Rights Reserved. 3
Objectives | Agenda
ďą Statutes and Regulations
ďą Definitions for Key Terms
ďą ISO 9000 and ISO 13485
ďą Detailed Analysis of Regulatory Requirements for Purchasing Control and
Acceptance
ďą Supplier: Principles and Planning
ďą Timing and Selection of Suppliers
ďą How to Evaluate Suppliers
ďą What and How to Implement Purchasing Control Requirements
ďą What to Do and How to Prepare for FDA Inspection on Purchasing Control
ďą Supplier Auditing: Decision Points
ďą What Items or Processes of the Suppliers to Audit
ďą How to Audit Suppliers
ďą Various Audit Approaches
ďą FDA Warning Letters based on 91 Cases for the Past 10 Years
ďą Common Deficiency
ďą How to Avoid 483s and Warning Letters
ďą Best Practices: Speakerâs Suggestions and Recommendations
4. Copyright Š 2014 REGULATORY DOCTOR. All Rights Reserved. 4
To see the complete presentation check the
below link:
http://www.audioeducator.com/pharma-biotech/medical-devices-better-control-
suppliers-12-09-2014.html