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Remote Auditing of Medical Device Suppliers During Covid-19
- 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
- When and how to conduct supplier audits
- 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
This 90-minute webinar will include:
- Understanding the regulations and expectations
- Lessons Learned
- Purchasing Controls Process
- Evaluation of Suppliers
- The balance between purchasing control and receiving inspection
- Which suppliers need to be audited
- Auditing Criteria
- Auditing Process
- Remote Auditing during Covid19
- Performance Management
- Feedback and Communication
- Best Practices
- Inspection Readiness
Overview of the webinar
The Covid19 pandemic has caused sudden disruption to the supplier management programs for many medical device companies. This webinar will help you update your approach to supplier auditing during the challenges of Covid19. 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 audits 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.
Who should attend?
- 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
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.
The Covid19 pandemic has created unique challenges for medical device companies to audit their suppliers. Supplier management requires clear information about your supplier’s strengths and weaknesses and the capability to consistently meet your requirements. And without an effective supplier audit program, supplier management lacks awareness of the issues within their suppliers. Management is blind to the problems with its suppliers and the risks that pose.
However, many companies conduct audits only because they are required to by regulation. Businesses often see supplier audits as a non-value-added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having a supplier audit program, management is often surprised by quality problems. This webinar can help you to avoid these problems.
Faculty - Miss.Susanne Manz
Susanne Manz 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. She 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.