A Bulletproof, Cost-Efficient Supplier Management Program
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management"
What about supplier quality? Your company must have a procedure in place
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot 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 a procedure in place that describes 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 great supplier control program in place.
• QSR and ISO 13485 requirements for supplier selection and assessment
• How to qualify new suppliers in a cost efficient manner
• How to assess current suppliers in a cost efficient manner
• How to perform supplier-related corrective action
• Minimum documentation requirements for supplier qualification, assessment, and related corective action
Who will Benefit
• Purchasing Departments
• Regulatory Departments
• Quality Assurance Departments
Industries who can attend
This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.