This 6-hour virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management 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 Purchasing Controls! This virtual seminar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.
You’ll learn about the essential elements of purchasing control and how you can translate them into your procedures. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.
Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations. This course will examine real-life warning letters to deepen your understanding of important concepts.
You’ll learn about the essential elements of purchasing control and how you can translate them into your procedures. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.
Why you should 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.Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations. This course will examine real-life warning letters to deepen your understanding of important concepts.
Learning Objectives:
- Understand QSR 820.50, 820.80, and ISO13485:2016
- Understand GHTF guidance
- FDA QSIT approach to inspection
- FDA authority over medical device manufacturers and their suppliers
- Develop a risk-based approach to supplier audits
- Understand the balance between purchasing control and receiving inspection
- Lessons Learned
Agenda
- Understanding the regulations
- FDA QSR and ISO13485
- GHTF guidance
- Authority and Scope
- The balance between Supplier Control and Receiving Acceptance
- Purchasing Controls Process
- Planning Purchasing Control and Supplier Management
- How supplier management fits into product development
- Supplier categorization
- Business risk
- Regulatory risk
- Medical Risk
- Planning for Supplier Selection
- What is being purchased
- Design Control and purchasing data
- Identify Risks (business, regulatory, medical)
- Identify Controls (business, regulatory, medical)
- Evaluation of Potential Suppliers
- Identify potential suppliers
- Evaluate the business capability
- Evaluate the operational capability
- Evaluate the quality capability
- Implementing Supplier Controls
- Receiving Inspection
- Risk-based audits
- Purchasing Data, Documentation
- Control Plan
- Quality Agreements
- Approved Supplier List (ASL)
- Supplier Auditing
- Audit teams
- Audit objectives
- Remote Audits
- Performance Management
- Supplier scorecards
- Standard metrics
- Maturity Models
- Supplier Reviews
- Supplier Corrective Action Requests (SCARs)
- Corrective and Preventive Action
- Feedback and Communication
- Inspection Readiness
- QSIT (Quality System Inspection Technique)
Speaker
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.Who Should Attend
- Quality Managers
- Supplier Engineers
- Supplier/Purchasing Managers
- Quality Engineers
- Supplier Quality Engineers
- Compliance Personnel
- Supplier Auditors
- Compliance Specialists
- Product and Process Engineers
- Design Engineers
