This 2-day 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.
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.
This seminar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters! Regulatory expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years’ experience in medical devices. The instructor has worked in manufacturing, design, quality and compliance at industry leaders like GE, Johnson and Johnson, and Medtronic. She is a published author and has traveled throughout the world developing, auditing, and improving quality systems.
Areas Covered:
- Comparison of Quality System Regulation (21 CFR 820) to ISO13485:2016
- Principles of Purchasing Controls and Supplier Management
- The differences between suppliers, contract manufacturers, contract sterilizers, contract designers, and others
- Regulatory Expectations
- How to “Establish and Maintain” a Quality System with Excellent Standard Operating Procedures
- Practical Approaches to an Efficient and Effective Quality Management System
- Lessons Learned from Case Studies and Warning Letters
- 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
- Corrective and Preventive Action
- Good Documentation
- Root Cause Analysis
- Tool Kit
- Inspection Readiness
Course Content
Day 01 (8:00 AM - 3:00 PM PDT)08.00 AM: Session Start
8:00 AM: Module 2
- 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
10:00 AM: Module 2
- Planning Purchasing Control and Supplier Management
- Supplier Management business process
- 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)
1:30 PM -3:00 PM: Module 4
- Evaluation of Potential Suppliers
- Identify potential suppliers
- Evaluate business capability
- Evaluate operational capability
- Evaluate quality capability
8:00 AM: Module 5
- Implementing Supplier Controls
- Receiving Inspection
- Risk-based audits
- Purchasing Data, Documentation
- Control Plans
- Quality Agreements
- Approved Supplier List (ASL)
10:00 AM: Module 6
- Supplier Auditing
- Audit teams
- Audit objectives
- Remote Audits
11:45 AM: Module 7
- Performance Management
- Supplier scorecards
- Standard metrics
- Maturity Models
- Supplier Reviews
- Supplier Corrective Action Requests (SCARs)
- Corrective and Preventive Action
- Feedback and Communication
1:30 PM -3:00 PM: Module 8
- Lessons Learned
- Inspection Readiness
- QSIT (Quality System Inspection Technique)
- Conclusions
Course Provider
Susanne Manz,
President and Principal Consultant ,
Manz Consulting, Inc.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.
Who Should Attend
- Quality System Specialists
- Internal Auditors, Managers, and Directors
- CAPA Specialists
- Compliance Managers or Directors
- Process Owners
- Quality Managers
- Supplier Managers
- Supplier Quality Engineers
- Supplier Auditors
- Product and Process Engineers
- Design Engineers
