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How to Meet FDA QSR and ISO 13485 Requirements - 2017

Start Date:
Monday, 1 May, 2017
End Date:
Monday, 1 May, 2017 11:00am
Business Practice

Overview: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 selectionQSR and ISO requirements for supplier assessment.Recommended processes for new supplier qualification in a cost efficient manner.Who Will Benefit: Supply chain managementPurchasing managementRegulatory managementQA managementExecutive ManagementSpeaker Profile: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.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email:


161 Mission Falls Lane,
Suite 216

Organizer Details

Conference organized by Compliance4ALL

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

161 Mission Falls Lane, Suite 216

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