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How to Meet FDA QSR and ISO 13485 Requirements – 2017
May 1 @ 10:00 am - 11:00 am$150
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly 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.
Why should you Attend:
This presentation will review the QSR and ISO requirements for supplier evaluation and assessment. It will also provide cost efficient and equally compliant options for many of the most common practices in supplier management programs.
Areas Covered in the Session:
QSR and ISO requirements for supplier selection
QSR and ISO requirements for supplier assessment.
Recommended processes for new supplier qualification in a cost efficient manner.
Who Will Benefit:
Supply chain management
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.
Compliance4All DBA NetZealous,
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