A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company’s purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.
Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered “approved.” You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain “approved.” You may never have to pay a visit to your supplier if you have a great supplier control program in place.
Areas Covered in the Session :
- QSR and ISO 13485 requirements for supplier selection and assessment
- How to qualify new suppliers in a cost efficient manner
- How to assess current suppliers in a cost efficient manner
- How to perform supplier-related corrective action
- Minimum documentation requirements for supplier qualification, assessment, and related corective action
Who Should Attend:
- Purchasing Departments
- Regulatory Departments
- Quality Assurance Departments