Purchasing Controls and Supplier Management for Medical Device Manufacturers

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

Who will benefit:

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

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
9:30 AM: Break
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
11:30 AM: Break
11:45 AM: Module 3
Planning for Supplier Selection
- What is being purchased
- Design Control and purchasing data
- Identify Risks (business, regulatory, medical)
- Identify Controls (business, regulatory, medical)
1:15 PM: Break
1:30 PM -3:00 PM: Module 4
Evaluation of Potential Suppliers
- Identify potential suppliers
- Evaluate business capability
- Evaluate operational capability
- Evaluate quality capability

Day 02(8:00 AM - 3:00 PM PDT)

8:00 AM: Module 5
Implementing Supplier Controls
- Receiving Inspection
- Risk-based audits
- Purchasing Data, Documentation
- Control Plans
- Quality Agreements
- Approved Supplier List (ASL)
9:30 AM: Break
10:00 AM: Module 6
Supplier Auditing
- Audit teams
- Audit objectives
- Remote Audits
11:30 AM: Break
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
1:15 PM: Break
1:30 PM -3:00 PM: Module 8
- Lessons Learned
- Inspection Readiness
- QSIT (Quality System Inspection Technique)
- Conclusions

Susanne Manz President and Principal Consultant, Manz Consulting Inc

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, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

Register Now

Location
Simu Live
(On-demand Streaming)

Online using Credit card

$1,499.00

(One Dial-in One Attendee)

(After registration, we will video stream the training
on your convenient dates)

$7,999.00

Group-Max. 10 Attendees

(After registration, we will video stream the training
on your convenient dates)

For discounts on multiple registrations, contact customer care at +1-888-771-6965.

Other Registration Options

By order form / PO#

Download the Order Form
Fill this form with attendee details & payment details
Fax it to +1-650-362-2367, or
Email it to customercare@fdatrainingalert.com

Payment Modes

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Terms & Conditions to Register for the Seminar/Conference/Event »

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future FDATrainingAlert event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event FDATrainingAlert cancels the seminar, FDATrainingAlert is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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Supplier and Contract Manufacturer Management for Medical Device Manufacturers