Training Course
Syllabus:
Effective Purchasing and Supplier Controls for Medical Device Manufacturers
Objectives of the Presentation
- Understanding the regulations
- Lessons Learned
- FDA Expectations
- Purchasing Controls Process
- Planning
- Evaluation of Suppliers
- Purchasing Data
- Performance Management
- Feedback and Communication
- Best Practice
Why Should you Attend
Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls.
Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations.
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