Loading ...

Questions? US: 1.800.472.6477 |EU: +353 21 212 8530
0
Contact us
[0] |

Let's get started

QA/RA Consulting, Auditing & Training

Combination Device Supplier Management Training

This course will provide your organization with the knowledge and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system for your combination product. As part of this course, you will identify recommendations for writing quality agreements with contract manufacturing organizations (CMOs) and auditing.

Send to a Colleague

Ask A Question

Compare Classes

Brief Overview of This Combo Product Supplier and Subcontractor Management Training Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEU)

2.4

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days.

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Combination Device Supplier Management Training Classes

SkillsLab $3295

SkillsLab $3295

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Class on Managing Combination Device Supplier and Subcontractor Quality

Supplier quality management issues continue to be a top observation in US FDA inspections and the source of numerous warning letters and 483s. In addition to compliance concerns, organizations face day-to-day supplier quality issues that pose significant risks, including production disruptions and high-profile recalls. This course will provide your organization with the knowledge and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system for your combination product. As part of this course, you will identify recommendations for writing quality agreements with contract manufacturing organizations (CMOs) and auditing.

Course Overview

SkillsLab Class

Defining Combination Products

Combination product terminology, definitions, and examples
Primary mode of action (PMOA) and its importance

Exercise!Identifying Combination Products

Introduction to Supplier Quality Management

Supplier-related concerns of stakeholders
Key terms
Combination product manufacturing scenarios
Challenges in supplier quality management

Regulatory Requirements and International Standards

ISO 13485:2016
Regulatory requirements:
1. US FDA 21 CFR Parts 4, 210, 211, and 820
2. European Union Medical Device Regulation (EU MDR)
3. European Medicines Agency (EMA) Pharmaceutical Legislation
Global Harmonization Task Force (GHTF) guidance
International Council for Hamonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Combination products regulatory strategy

Supplier Quality Management Overview

The process approach and risk-based thinking
Overview of ISO 13486:2016 Clause 7.4 Purchasing
Outputs / feedback for supplier quality management system (QMS) improvement

Product and Supplier Requirements Determination

Quality system planning activities for outsourced QMS processes
Design process and supplier quality management (SQM)
Traceability
Purchased product and supplier requirements

Exercise!Determine Requirements

Supplier Evaluation, Selection, and Approval

Supplier evaluation and selection requirements
Supplier evaluation criteria
Risk-based thinking in supplier evaluation, selection, and approval
Evaluation methods
Supplier selection and approval criteria

Exercise!Create Tool

Exercise! Evaluate Suppliers

Quality Agreements

Supplier and quality agreements
Quality agreement requirements, contents, and best practices
Approved supplier list (ASL) documentation
Change notifications
Supplier QMS impacts on operational risks

Exercise!Quality Agreement

Supplier Monitoring and Reevaluation Process

Supplier monitoring and reevaluation
Supplier performance reviews and scorecards

Exercise! Supplier Monitoring Plan

Supplier issues and disqualification
Related QMS processes:

Corrective and preventive action (CAPA) / nonconformities
Management review

European Medicines Agency (EMA) Pharmaceutical Legislation

Verification of Purchased Product

Verification of purchased product
Verification methods
Supplier change notification
Risk-based statistical methods for verification

Exercise!Verification Plan

Auditing

Auditing basics
US FDA inspections
Medical Device Single Audit Program (MDSAP)
Inspections and audits preparation

What You Will Learn

At the conclusion of this training class, you will be able to

SkillsLab

Identify regulatory requirements and international standards for supplier quality management applicable to combination products, including ISO 13485:2016, US FDA, ICH, and the EU Medical Device Regulation

Describe the life cycle of supplier quality management

Establish a risk-based process for evaluating, selecting, and reevaluating suppliers

Translate product development and manufacturing needs into purchased product and supplier requirements

Identify and appropriately manage outsourced processes through the supplier quality management system

Identify requirements for quality agreements applicable to combination products

Develop and maintain an approved supplier list

Develop an effective supplier quality monitoring and measurement process

Plan and implement an effective process for verifying purchased product

Identify auditing and inspection techniques and best practices

Manage supplier nonconformances and escalation of issues through the supplier quality management and related quality management system processes

Identify current and emerging topics in supplier quality and global supply chain management

Who Should Attend

Designed for personnel involved in sourcing, securing, and maintaining suppliers for combination products that ensure excellent product quality and organizational reputation, including supplier quality and procurement / supply chain managers; product development engineering managers; management representatives; product, project, and program managers; RA/QA managers / engineers; auditors; and other cross-functional team members.

Supplier Quality Professionals
Supplier Procurement Managers
Supply Chain Managers
RA/QA Managers
Product Development Engineers

Related Courses & Services

Related Courses and Services

Starting Soon!

See all Medical Device RA/QA training classes scheduled to begin in the next 90 days

See Upcoming Classes

Full Training Catalog

See our full offering of 30+ medical device & IVD courses

Download our Current Training Catalog

Private Training

A customizable, cost-effective solution to train your team.