Overview
This 2-day virtual seminar 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 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.
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.
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
Agenda
This 2-day virtual seminar will focus on establishing an effective and efficient system of purchasing controls. Topics to be covered include:
Day One (10am -4:30 pm)
- Module 1 (10am -11:30am)
- Understanding the regulations
- FDA QSR and ISO13485
- GHTF guidance
- FDA Expectations
- Authority and Scope
- Balance between Supplier Control and Receiving Acceptance
- Purchasing Controls Process
- Purchasing Data
Break
Module 2 (11:45am -1pm)
- Planning Purchasing Control and Supplier Management
- Supplier Management business process
- Supplier categorization
- Business risk
- Regulatory risk
- Medical Risk
Lunch
Module 3 (1:30pm – 3pm)
- Planning for Supplier Selection
- What is being purchased
- Design Control and purchasing data
- Identify Risks (business, regulatory, medical)
- Identify Controls (business, regulatory, medical)
Break
Module 4 (3:15-4:30pm)
- Evaluation of Potential Suppliers
- Identify potential suppliers
- Evaluate business capability
- Evaluate operational capability
- Evaluate quality capability
Day Two (10am-4:30pm)
Module 5 (10-11:30am)
- Implementing Supplier Controls
- Control Plan
- Receiving Inspection
- Risk-based audits
- Purchasing Data
- Quality Agreements
Break
Module 6 (11:45am – 1pm)
- Performance Management
- Supplier scorecards
- Standard metrics
- Maturity Models
- Supplier Auditing
Lunch
Module 7 (1:30pm – 3pm)
- Feedback and Communication
- Supplier Reviews
- Supplier Corrective Action Requests (SCARs)
- Corrective and Preventive Action
Break
Module 8 (3:15 – 4:30pm)
- Lessons Learned
- Inspection Readiness
- Conclusions
Who Will Benefit
- Medical Device Companies
- Quality Managers
- Supplier Engineers
- Supplier/Purchasing Managers
- Quality Engineers
- Supplier Quality Engineers
- Compliance Personnel
- Supplier Auditors
- Compliance Specialists
- Product and Process Engineers
- Design Engineers
Faculty Susanne Manz
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices including roles as Worldwide Director of Design Quality, Worldwide Director of Product Quality, Executive Business Consultant, and Director of Corporate Compliance. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications in Six Sigma while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification from RAPS and Quality Auditor Certification from the American Society for Quality.
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