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Sara Dyson to Present at Supplier Quality Management Congress
Managing Risk in the Supply Chain

Place

Bethesda North Marriott Hotel and Conference Center, Bethesda, MD

Start Date & Time

August 9, 2011

End Date & Time

August 11, 2011

Registration Information

Description

Sara Dyson, Medmarc's Assistant Vice President of Loss Control, will speak at the Third Annual Supplier Quality Management Congress on August 11th about "Managing Risk in the Supply Chain".

Despite the FDA’s ongoing work with international regulators to improve supplier quality issues, a top FDA official has stated that another public health crisis like Heparin “seems inevitable.”

The number of offshore suppliers has nearly tripled in recent years. China alone has nearly 1,000 makers of drug substances and only a small percentage of inspections.

Whether you make drugs or devices, biologics or third-party goods, when your suppliers slip up, it’s you the FDA comes after. Ideally, the regulators should be covering your back with tough inspections of offshore suppliers … but realistically, the agency simply is spread too thin to do the job.

Learn how to assure the integrity and quality of your supply chain. Put yourself at the head of the class and avoid 483s … warning letters … lawsuits … by taking the lead.

Take charge of your supply chain by joining the top speakers in Washington for the tools you need.   

Key issues include:

  • The FDA outlook on supplier quality and compliance
  • How to create comprehensive supplier quality agreements
  • An assessment tool for choosing the right supplier
  • How to conduct on-site supplier audits applying best practice risk management techniques
  • Supplier metrics and their role in the QMS management review
  • Can’t-miss audit plans and supplier quality auditor training programs
  • Special for device makers: Updates on GHTF and device outsourcing trends
  • Special for drug and biologics manufacturers: Creating qualification management systems  
  • Who will benefit by attending: 

    Quality assurance/quality control, Operations, Manufacturing, Materials management, Purchasing, Packaging and labeling, Plant engineering, Laboratory quality control, Regulatory affairs and Legal counsel.