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
FDA Faculty Susanne Manz

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.  

Choose a Purchase Option


$1,295

One Dial-in One Attendee – Live

Early Bird $1295 Regular Price $1985 Less

You get one log-in for the live virtual seminar for one participant , presentation materials , Certificate and the opportunity to ask questions by phone and email.

$3,995

Group-1- 5 Attendees - Live + 12 month Access

You get Group log-in for the live virtual seminar for max 5 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access is Included for 1 year for the Group.

$1,895

Recorded Access Single Attendees – 6 month

You'll have 12 month access to single log-in for an archived recording of the entire 2 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$4,985

Recorded Access Group-1-10 Attendees -12 month

You'll have 12 month access to group log-in up to 10 attendees for an archived recording of the entire 2 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

 

Our Past Seminar Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals