This Supplier control webinar will explore the regulatory requirements for supplier controls by medical device manufacturers and will review the recommendations by the GHTF for manufacturers of medical devices.
Why should you Attend:
The US FDA has discovered that a reasonably large number of recalls and adverse events are related to supply product. Medical device supplier activities are now a focus area for FDA inspections and also third party audits. This concern is now reflected internationally with the publication of a GHTF guidance document on supplier activities. This increased focus by regulators on supplier activities should cause medical device companies to review their processes against requirements to avoid audit and inspection findings.
This presentation will explore the regulatory requirements for supplier controls by medical device manufacturers. It will review the recommendations by the GHTF for manufacturers of medical devices. The presentation will also review best practices in supplier controls and how to meet new expectations of regulators in supplier management. Implementation of a compliant Supplier Management system will lead to lower cost by working with suppliers in key areas to reduce supply chain problems.
Areas Covered in the seminar:
- Supplier Controls reduce supplier problems.
- Supplier evaluation techniques lead to selection of better suppliers.
- Supplier selection processes must be effective in choosing the right suppliers.
- Acceptable Supplier Listings are used to show what products suppliers can efficiently provide.
- Removing suppliers from Acceptable Lists when there are issues.
- Impact of Risk Management on Supplier processes.
- How to develop a Supplier Management process that meets regulators expectations.
- Supplier contracts must have several key elements to meet regulatory requirements.
Who will benefit:
This presentation will help those responsible for supplier activities, including those from purchasing organizations, quality organizations and also those in design groups that interface with suppliers and design purchased components and products. Selecting the right supplier and providing the proper interface between supplier and customer can reduce costs and improve responsiveness.
- Purchasing Managers
- Purchasing Agents
- Supplier Quality Engineers
- Design Engineers
- Quality Managers
- Engineering Managers
Instructor Profile:
Edwin L. Bills, is the Principal Consultant for Bilanx Consulting LLC, a consulting firm that provides assistance to medical device companies in compliance with US FDA regulations, in development of Quality Management Systems and Risk Management processes. Edwin has over 20 years experience in the medical device industry and has participated in development of industry standards, including ISO 14971. In his consulting role he has assisted companies in Warning Letter responses. Edwin has also participated in training both company and FDA personnel in the Quality System Regulation and Product Risk Management.
