Live webinar Supplier Management in a Compliant, Cost-Efficient Manner

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minutes

Webinar Includes : All the training handouts , Certificate ,Q/A and 60 mins Live Webinar.


Join This course On March 27, 2017 at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

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. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe 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 good supplier control program in place.

Why one should attend the training

Supplier qualification and assessment is required according to both QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this.
Organizations can, however, spend much less time and money, and still be in control of their suppliers and in compliance with the regulations. 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

• 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.
• Recommended processes for current supplier assessment in a cost efficient manner.
• Supplier-related corrective action: Practices, Documentation, and Follow-up.
• Implementation of a lean system for supplier qualification, assessment, and related corrective action.

Who will Benefit

This webinar will provide valuable assistance to all regulated companies that are interested in implementing a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:
• Supply chain management
• Purchasing management
• Regulatory management
• QA management
• Executive Management

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Jeff Kasoff

FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

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