Supplier Auditing for Medical Device Companies
In this webinar, you will learn about the essential elements of supplier audits. We will also discuss the process steps for supplier control and how it relates to other parts of your QMS including receiving and acceptance activities.
May 18, 2020
10:00 AM PDT | 01:00 PM EDT
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Product Id : 502946
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers.
Learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers.
You'll learn about the essential elements of supplier audits. We'll discuss the process steps for supplier control and how it relates to other parts of your QMS including receiving and acceptance activities.
A well-designed supplier audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.
Why should you Attend:
Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls.
Supplier management requires clear information about your supplier's strengths and weaknesses and capability to consistently meet your requirements. And without an effective suppler audit program, supplier management lacks awareness of the issues within their suppliers.
Management is blind to the problems with their suppliers and the risks that poses.
However, many companies conduct audits only because they are required to by regulation. Businesses often see supplier audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes.
And despite having supplier audit program, management is often surprised by quality problems. This webinar can help you to avoid these problems.
Areas Covered in the Session:
- Understanding the regulations and expectations
- Lessons Learned
- Purchasing Controls Process
- Evaluation of Suppliers
- Balance between purchasing control and receiving inspection
- Which suppliers need to be audited
- Auditing Criteria
- Auditing Process
- Performance Management
- Feedback and Communication
- Best Practices
- Inspection Readiness
Who Will Benefit:
- Responsibilities for supplier management and purchasing controls
- Balance between supplier management and receiving inspection
- Enforcement case studies and lessons learned
- Quality agreements
- Using a structured program to identify areas of risk leading to an effective audit strategy
- How to develop a meaningful structure of oversight, audit, transparent communication, and escalation to management review
- Audit planning, execution, and follow-up
- How to ensure management gets valuable information from your audit program
- Supplier Engineers
- Supplier Auditors
- Supplier/Purchasing Managers
- Quality Engineers
- Supplier Quality Engineers
- Compliance Personnel
- Compliance Specialists
- Quality/Compliance managers or directors for Medical Device companies
- General Managers wanting to learn how to Management Review and expectations
Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.
She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.