BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T093028Z UID:fa3afe95-e5c8-403e-85ed-8deed9fbdf10 DTSTART:20210413T090000 DTEND:20210414T090000 CLASS:PRIVATE DESCRIPTION:
Supplier qualification and assessment is required in both th e QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend signific antly less time and money\, and still be in control of their suppliers and in compliance with the regulations. This class will review the QSR and IS O requirements for supplier evaluation\, including defining the types of s uppliers that require evaluation. The QSR/ISO requirements for supplier as sessment will be defined as well. Attention will be paid to inclusion of r isk management in across both supplier qualification and assessment\, impl ementation of which will allow your company to devote value-added resource s to these efforts. Significant time will be spent on discussion of the to pic of supplier nonconformance\, including how and when to issue the dread ed Supplier Corrective Action Request. Your supplier nonconformance handli ng process must be nonconfrontational\, or even better\, collaborative. If your company is too demanding of your suppliers\, you risk alienating the m or even worse losing them - try explaining that to your supply chain fol ks.
\n\nNotified bodies an d the FDA cannot require your suppliers to meet the quality system regulat ions\, so they must make sure you are exercising sufficient control over t hose suppliers. You must make sure your supplier management and system mee ts all required regulations and guidance documents\, especially for outsou rced processes such as contract manufacturing\, sterilization and testing\ , and also for critical suppliers. Sure\, you depend on your suppliers to provide you with goods and services\, but can your system prove that you h ave sufficient control over your suppliers to assure auditors and regulato ry agencies that your product is safe and meets all your requirements? You r supplier management program can be in compliance\, but is it cost effect ive? If not\, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If yo ur company is too demanding of your suppliers\, you risk alienating them o r even worse losing them - try explaining that to your supply chain folks!
\n\nThis se minar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:
\n\nLecture 1: \;Introduction
\nSupplier Select
ion
Lecture 2: \;
\nSupplier Selectio
n (cont)
Lectur
e 3: \;
\nSupplier Assessment
Lecture 4: \;
\nSupplie
r Assessment (cont)
Lecture 1: \;
\nS
upplier Nonconformance
Lecture 2: \;
\nSupplier Nonconformance (
cont)
Le
cture 3: \;
\nWorkshop
Lecture 4: \;\nQ&\;A - Conclusion
\n
\n \;
Jeff Kasoff\, \;RAC\, CMQ/OE is the Principal Consultant at Lean to Quality\, LLC. He s has more than 3 0 years of experience 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 mi llion in revenue. This multi-faceted experience makes Jeff uniquely qualif ied to address compliance issues across the entire range of company sizes.
\n\nJeff has also been primary liaison with FDA inspectors and noti fied body auditors\, giving him first-hand experience with the most common issues surfaced by regulatory agencies.
\n\nJeff received his Regul
atory Affairs Certification from RAPS\, his Manager of Quality and Organiz
ational Excellence certification from ASQ\, and his Lean Black Belt from I
IE
\n
\nPlease contact Marilyn Turner: Phone: +1 929 900 1853 &n
bsp\;Email: marilyn.turner [a] nyeventslist.com for registrations