Course Description:

Regulatory requirements for medical device companies seem to constantly undergo review and change, with increased emphasis on specific aspects based on recall, error and warning letter trends. Recent recalls of medical devices due to failures of critical components and services supplied to device manufacturers have resulted in increased scrutiny of Purchasing and Supplier Controls. The result is that manufacturers now bear the responsibility for every step in their supply chain to ensure they provide quality finished medical devices beyond what can be achieved through testing and inspection, meaning overall quality depends on quality of raw materials, components and services. In addition, manufacturers must make sure that all aspects of the supply chain are compliant with regulatory and quality system requirements.

But how do you account for all the raw material, components and services provided by your suppliers, let alone ensure they are aware of and comply with regulatory requirements?

In this two day seminar you will identify the various purchasing and supplier control requirements of the FDA QSR, EU MDR and ISO 13485: 2016, learn how these controls pertain to products, components and services, translate these requirements into actionable controls for your suppliers, and describe the links between purchasing controls and other quality system requirements such as design and acceptance activities. We will share current processes, challenges and best practices related to purchasing and supplier controls and develop quality plans for incorporating requirements and controls into your quality system.



Learning Objectives:

Upon completing this course, participants should be able to:

  • Understand the purchasing and supplier control requirements of the FDA QSR, EU MDR and ISO 13485: 2016
  • Evaluate effectiveness and applicability of these controls for their suppliers, raw materials, components and services using a risk based approach
  • Develop successful quality plans for incorporating requirements into the quality system
  • Select suppliers based on their capabilities to meet regulatory and manufacturing requirements
  • Establish procedures and records showing adequate supplier control
  • Establish robust and clear supplier agreements

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar



Who will Benefit:

This course is designed for people responsible for following purchasing procedures, those tasked with developing and improving purchasing and supplier controls including approval of suppliers, components, raw materials and services, and individuals responsible for quality management system improvements and compliance.

Following personnel will benefit from the course:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Purchasing supervisors
  • Manufacturing engineers
  • Design engineers
  • Quality engineers
  • Document control specialists




Course Outline:

DAY ONE (8:30 AM – 4:30 PM) DAY TWO (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Understanding the Basics of a Quality Management System
    • Terms & Definitions
    • References & Standards
    • Quality Principles
  2. Regulatory Requirements for Purchasing and Supplier Controls
    • FDA QSR
    • ISO 13485: 2016
    • EU MDR (proposed changes unless approved)
  3. Customer vs Supplier Requirements
    • Identification of Requirements
    • Reconciliation of Requirements
    • Mediation of Differences
  4. Identifying Purchasing Controls
    • Creating the Purchasing Process
    • Creating the Control Plan
    • Documentation of Specifications
    • Product/Service Evaluation
  5. Identifying Supplier Controls
    • Creating the Control Plan
    • Supplier Selection, Evaluation & Review
    • Control of Customer-Supplied Product
    • Receiving Inspection & Product Acceptance
    • Supplier Agreements
  6. Monitoring of Controls
    • Supplier Metrics
    • Internal Metrics

  1. Verification of Purchased Product
    • Incoming Inspection Activities
    • Identification & Traceability Requirements
  2. Using Risk to Evaluate Effectiveness & Applicability of Controls
    • Performing a Risk Assessment
    • Business Risk
    • Regulatory Risk
    • Product Risk
    • Risk vs Benefit Assessment
  3. Feedback & Communication
    • Manufacturer to Supplier
    • Changes to Specifications
    • Changes to Inspection Criteria
    • Changes to Regulatory Requirements
    • Supplier to Manufacturer
    • Changes to Supply
    • Changes to Equipment & Material
    • Changes Impacting Quality (known & unknown)
  4. Evaluation & Improvement
    • Auditing Suppliers
    • Supplier Corrective Actions
    • Supplier Scorecards
  5. Incorporating Purchasing & Supplier Controls into the QMS
    • Quality Manual
    • Operating Procedures- management review, CAPA, change control,
    • Work Instructions
    • Forms




Meet Your Instructor

Lena Cordie
Quality & Regulatory Consultant

Ms. Cordie has over 20 years experience in quality and regulatory affairs in the medical device, call center and retail markets, specializing in integrating electronic QMS modules, implementation of agile labeling programs, including color labels and barcodes, and cleanrooms for medical device production. She has been a member of Regulatory Affairs Professionals Society (RAPS) since 2005.

Key Surgical products focus on Central Sterile Departments and Ms. Cordie represents the company as a voting member of the Association for the Advancement of Medical Instrumentation (AAMI) since 2007. Ms. Cordie is very active in a number of working groups drafting Sterilization Standards related to surgical instrument cleaning and reprocessing and is a US delegate to the ISO/TC 198 Sterilization of Health Care Products committee.





Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

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 @ +1-888-717-2436 or email us @ [email protected]

Payment:
Payment is required 2 days before 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 $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline 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 ComplianceOnline cancels the seminar, ComplianceOnline 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 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners

Sponsors



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.






Local Attractions

The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.

Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.




With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.

The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.




The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.




The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”



An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.

Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.




The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.




One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.




Franklin Square, one of Philadelphia’s five original public squares laid out by William Penn in his original plan for the city, has undergone a dramatic renovation. The park now boasts several family-friendly attractions, including a miniature golf course, classic carousel, burger joint, storytelling bench, picnic area and more.






We need below information to serve you better

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method