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Supplier Management: How to meet FDA QSR and ISO 13485 requirements in a cost-effective manner
Supplier Selection
- Review of FDA and ISO requirements
- Types of suppliers that must be qualified
- Defining critical suppliers
- Classification of suppliers
- Outsourced processes
- The Quality Agreement
- Recommended Practices
Supplier Assessment
- Review of FDA and ISO requirements
- Recommended Practices
- How to avoid “Death by Supplier Audit”
- Documentation requirements
Overview of the webinar
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meet all required regulations, especially for critical suppliers.
This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.
- Understanding of QSR requirements for supplier evaluation, and their application
- Understanding of ISO requirements for supplier evaluation, and their application
- Definition of types of suppliers, and those that require evaluation
- Best practices for “critical” suppliers and outsourced processes
- Understanding of QSR requirements for supplier assessment, and their application
- Understanding of ISO requirements for supplier assessment, and their application
- Application of risk-based process resulting in a customized supplier management system
Who should attend?
This webinar 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:
- Supply Chain Management
- Buyers
- Purchasing Management
- CAPA Coordinators
- Regulatory Management
- QA Management
- Executive Management
- Internal Auditors
Why should you attend?
Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them - try explaining that to your supply chain management!
Faculty - Mr.Jeff Kasoff
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 startup 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. Jeff 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 in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.