2:00PM –2:25PM

Abstract:
The Purchasing requirements in the 21 CFR 820 and ISO 9001:2008 / ISO 13485:2003 standards help to ensure that products and services you purchase from various suppliers fully meet your needs so that you can, in turn, satisfy your customers. Many firms however feel that they are adequately auditing and managing suppliers yet find they are having myriads of quality issues. For the past few years, heavy focus has been on supplier management during customer and regulatory audits to ensure that products and services meet customer requirements and patient safety is not compromised.

Does your organization struggle to effectively manage suppliers? Does your organization having recurring quality related issues with parts/services purchased from your suppliers after for cause audit and taking corrective actions? This presentation will outline regulatory requirements for managing suppliers in a sensible way that will protect your products, budget while mitigating risk to patient safety.

Intended audience: Procurement, Quality Assurance, Regulatory Compliance, Buyers/Planners, Product Development, Manufacturing

• ISO and FDA requirements fir Supplier Qualification
• Risk-based Supplier Evaluation, Selection, and Management Process
• Supplier Risk Assessment tool
• FDA focus on supplier related issues
• Tips for selecting and training auditors

About the speaker:
Bob Mehta, FDA/ISO Compliance & Quality System Advisor

Bob Mehta is a FDA/ISO Compliance & Quality System consultant at GMP ISO Expert Services (www.gmpisoexpert.com). He provides retainer/advisor/consultant services to the medical device, pharma, and biotech companies and to their suppliers. Bob has over 20 years of experience in Quality Assurance, Quality Control, Supplier Quality, and Regulatory Compliance areas.

Bob is an adjunct instructor at University of Redlands, UC Riverside, and North Orange County Community College. He teaches courses on Risk Management and ISO/FDA Quality Systems requirements. Bob has presented at various conferences on Quality-by- Design, Risk Management, Quality Systems, Product Recall and Supplier Quality related topics.

Bob possesses MSQA, MBA, and B.S. (Chemistry) degrees. He possesses 7 ASQ certifications - CSSBB, CQE, CRE, CSQE, CBA, CPGP, CQA, and a Lean Pharma certification from Michigan School of Engineering. Bob currently serves as ASQ Section 0701 Outreach Chairman.