courses

ISO 13485:2016 Medical Devices, FDA, EU MDR, & MDSAP

Why was ISO 13485 revised?

ISO 13485:2016 sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.


What does ISO 13485:2016 include?

With the standard applicable to so many types of products, the revision was no easy task. A medical device is any product intended for use in the diagnosis, prevention and treatment of medical conditions. They range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines and diagnostic reagents.


How is the new ISO 13485:2016 better?

Improvements in the latest version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements, and a greater focus on post-market surveillance including complaint handling.

There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.

Read more on ISO.org

 

Axeon is an Exemplar Global Certified Training Provider.

Early Bird Pricing

4-Day ISO 13485:2016 with FDA 21 CFR 820

Lead Auditor Training Course

 

Online-Virtual Classroom

 

4 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced

Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Lead Auditor Certification in Medical Device Quality Management Systems.

 

Overview 

This course prepares you to perform effective audits of Medical Device Quality Management Systems.  You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization.  We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

·      quality managers Also:
·      management representatives ·      quality consultants
·      audit program managers ·      Those who perform supplier audits
·      regulatory affairs specialists ·      Those who perform third-party (ISO certification) audits
·      lead auditor candidates ·      Managers who are audited in QMS audits
·      internal auditors ·      Those involved in designing a QMS for their organizations
·      top management

 

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 13485:2016.  Most students will be able to obtain a copy from their company.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard and 21 CFR 820
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

Day 1

1

Course Introduction

2

History of Quality Management

3

In-depth Review of Standard

4

Exercise: Audit Case Studies

Day 2

1

Learning Game on Pre-assignment

2

Test on Standard

3

Review Test

4

Review 21 CFR 820 & Exercise

5

AU Module – Part 1. Intro to Auditing

6

Test on Part 1 / Review Test

7

Part 2. Preparing for an Audit

Day 3

1

Test on Part 2 / Review Test

2

Part 3. Conducting the Audit

3

Test on Part 3 / Review Test

4

Audit Role Play Exercise 1

5

Part 4. Completing the Audit

6

Test on Part 4 / Review Test

7

Exercise: Writing Audit Findings

Day 4

1

TL Unit: Leading an Audit Team

2

Audit Role Play Exercise 2

3

Exercise: Conducting a Closing Meeting

4

Writing the Audit Report

5

Test on TL Unit / Review Test

6

Class Wrap-Up

4-Day ISO 13485:2016 with FDA 21 CFR 820

Lead Auditor Training Course

 

4 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced

 

Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Lead Auditor Certification in Medical Device Quality Management Systems.

Overview 

This course prepares you to perform effective audits of Medical Device Quality Management Systems.  You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization.  We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

·      quality managers Also:
·      management representatives ·      quality consultants
·      audit program managers ·      Those who perform supplier audits
·      regulatory affairs specialists ·      Those who perform third-party (ISO certification) audits
·      lead auditor candidates ·      Managers who are audited in QMS audits
·      internal auditors ·      Those involved in designing a QMS for their organizations
·      top management

 

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 13485:2016.  Most students will be able to obtain a copy from their company.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard and 21 CFR 820
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

Day 1

1

Course Introduction

2

History of Quality Management

3

In-depth Review of Standard

4

Exercise: Audit Case Studies

Day 2

1

Learning Game on Pre-assignment

2

Test on Standard

3

Review Test

4

Review 21 CFR 820 & Exercise

5

AU Module – Part 1. Intro to Auditing

6

Test on Part 1 / Review Test

7

Part 2. Preparing for an Audit

Day 3

1

Test on Part 2 / Review Test

2

Part 3. Conducting the Audit

3

Test on Part 3 / Review Test

4

Audit Role Play Exercise 1

5

Part 4. Completing the Audit

6

Test on Part 4 / Review Test

7

Exercise: Writing Audit Findings

Day 4

1

TL Unit: Leading an Audit Team

2

Audit Role Play Exercise 2

3

Exercise: Conducting a Closing Meeting

4

Writing the Audit Report

5

Test on TL Unit / Review Test

6

Class Wrap-Up

3-Day Process & Software Validation

 

Days: 3

Time:  7:30 a.m.- 4:30 p.m. MDT

Audience: Beginner to Advanced

 

Overview

Our process & software validation training course is ideal for professionals in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who are tasked with process and/or software validation.

Who Should Attend?

  • Those responsible for planning and operating a compliant validation program.
  • Key players such as Process Engineers, Operations, Quality, and Regulatory personnel.
  • R&D, Design Engineers, and Product Formulators who translate product requirements into manufacturing requirements.

Agenda

  1. Introduction to Process Validation
  • Regulatory Perspective
    • Understand the key concepts of Process/Software validation in the Life Cycle of the medical device
    • Recognize the role process/software validation play of the safety and effectiveness of process outputs
    • Study the requirements of a Validation Protocol:(IQ) Installation Qualification, (OQ) Operational Qualification and (PQ) Performance Qualification
    • Understand the perspectives of the FDA, international regulators, and the GHTF
  • Process Validation Requirements
    • Verification vs. Validation decision
    • Regulatory Process/Software Validation guidance documentation
    • Requirements of 21 CFR cGMPs
    • Requirements of ISO 13485 and ISO 14971
    • Recommendations of GHTF SG-3
    • Approaches to validation (i.e. prospective, concurrent, and retrospective validation)
  • Elements of Process Validation Planning
    • Master Validation Plan
    • Statistical methodology Overview:  Capability Studies Cp and Cpk, Control Charts, Challenge Test, Design of Experiments, FMEA, Poka Yoke, Robust Design
    • Validation Methodology
    • Validation Method:
      1. Validation Team
      2. Validation Master Plan

Group Exercises:  Validation vs. Verification; Process Capability; Validation Master Plan;

  1. Process Validation Methodology cont.
  • Validation Protocol Development
  • Phases: DQ, IQ, OQ, PQ
  • Addressing Deviations
  • Final Report
  • Installation Qualification and Concepts
  • Operational Qualification and Concepts
  • Performance Qualification and Concepts
  • Process Validation Final Report
  • Maintaining State of Validation
  • Evaluating Changes in Validated Processes: Need for Re-validation/Partial Re-validation
  • Validation Case Studies:
    • Prepping for an IQ
    • Review an IQ

 

Group Exercises:  Validation Protocol Template; Review of Validation Protocol Case; Installation Qualification Template; Review Installation Qualification Case; Operational Qualification Template; Operational Qualification Case; Performance Qualification Template; Performance Qualification Case; Prepping for an IQ; Review an IQ

 

 

III. Software Validation

  • CDRH:  FDA Software Validation Guide
    • FDA Study of MD Recalls due to Software issues
    • Design Validation of Software
  • Principles of Software Validation
    • SRS:  Software Requirements Specification
    • Defect Prevention
    • Software Life Cycle
    • Software Validation Plan
    • Classic “V” Diagram
      1. Functional Specifications
      2. Design Specifications
      3. IQ Tests
      4. OQ Tests
      5. PQ Tests
      6. Reporting
  • Test Case: Log In Page Software Application
  • Software Validation Procedure
  • Software Validation After Change
  • Independence of Review
  • Flexibility and Responsibility
  • Software Validation Tasks
    • Testing by the Software Developer
    • Validation of Automated Process Equipment and Quality System Software
    • Define User Requirements
    • Validation of COTS software
  • Which software systems need validation?
  • Documentation required for a software validation
    • SRS
    • Software Verification Protocol
    • Software Verification and Validation Report
  • 10-Steps to Software Validation
    • User Requirements
    • Project Plan
    • Functional Specifications
    • GAP Analysis
    • Installation Protocol
    • Installation Report
    • Testing Protocol
    • Testing Report
    • System Release/Go Live
    • Validation Completed

Individual Exercise: In-Class Log In Page; Prepping for an OQ; Review OQ Case; Prepping for PQ; COTS Software Testing; V&V Traceability Matrix

MDSAP Training Course 

We teach you how to use auditing to improve your organization

 

3 Day Schedule: 7:30 AM- 4:30 PM MST
CEU Hours: 2.4
Audience: Beginner to Advanced

 

Overview

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply a proper interpretation of the ISO 13485 standard and MDSAP requirements to real-life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing and apply MDSAP and ISO 13485 requirements. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.
 

Who Should Attend

Individuals who will perform audits to regulatory requirements or Quality Management Systems, individuals assisting their organizations toward ISO 13485 registration or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
 

Prerequisites

There are no required prerequisites, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful.  All attendees are required to bring their own copy of the ISO 13485 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.
 

Course Objectives

  • Prepared to conduct a solo internal audit at successful course completion
  • Understand the MDSAP audit model.
  • Understand and interpret the ISO 13485 requirements and review applicable MDSAP requirements.
  • Apply the proper interpretation of the standard in actual audit situations.
  • Understand process auditing tools leading to substantive quality system improvements
  • Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  • Follow-up and resolve “audit trails that present themselves during the audit interviews
  • Conduct audits that result in real improvements to the quality system
  • Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

3-Day ISO 13485:2016 with FDA 21 CFR 820

Internal Auditor Training Course

 

3 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced

Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

Overview 

This course prepares you to perform effective audits of Medical Device Quality Management Systems.  You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization.  We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

·      quality managers Also:
·      management representatives ·      quality consultants
·      audit program managers ·      Those who perform supplier audits
·      regulatory affairs specialists ·      Those who perform third-party (ISO certification) audits
·      internal auditors ·      Managers who are audited in QMS audits
·      top management ·      Those involved in designing a QMS for their organizations

 

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 13485:2016.  Most students will be able to obtain a copy from their company.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard and 21 CFR 820
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

Day 1

1

Course Introduction

2

History of Quality Management

3

In-depth Review of Standard

4

Exercise: Audit Case Studies

Day 2

1

Learning Game on Pre-assignment

2

Test on Standard

3

Review Test

4

Review 21 CFR 820 & Exercise

5

AU Module – Part 1. Intro to Auditing

6

Test on Part 1 / Review Test

7

Part 2. Preparing for an Audit

Day 3

1

Test on Part 2 / Review Test

2

Part 3. Conducting the Audit

3

Test on Part 3 / Review Test

4

Audit Role Play Exercise 1

5

Part 4. Completing the Audit

6

Test on Part 4 / Review Test

7

Exercise: Writing Audit Findings

3-Day ISO 13485:2016 with FDA 21 CFR 820

Internal Auditor Training Course

 

3 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced

Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

Overview 

This course prepares you to perform effective audits of Medical Device Quality Management Systems.  You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization.  We also cover the requirements of 21 CFR 820, the federal regulations governing medical device management systems.  We’ll take you through the full audit process, including: audit planning and preparation, opening meetings, document review, interviewing auditees, closing meetings and reporting.  Training includes easy-to-use tools to simplify the auditing process.

This is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, role-plays, and other real-life practice exercises to keep the training active and build competence.

Who Should Attend?

·      quality managers Also:
·      management representatives ·      quality consultants
·      audit program managers ·      Those who perform supplier audits
·      regulatory affairs specialists ·      Those who perform third-party (ISO certification) audits
·      internal auditors ·      Managers who are audited in QMS audits
·      top management ·      Those involved in designing a QMS for their organizations

 

Prerequisites

None.  Our students range from seasoned quality professional to novices.  Our goal is to meet everyone at their current level of competence and increase it.  All students are required to bring their own printed copy of ISO 13485:2016.  Most students will be able to obtain a copy from their company.

Course Objectives

  • Help you develop the knowledge and skills required to become a Lead Auditor.
  • Improve your understanding of the International Standard and 21 CFR 820
  • Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs)
  • Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

Day 1

1

Course Introduction

2

History of Quality Management

3

In-depth Review of Standard

4

Exercise: Audit Case Studies

Day 2

1

Learning Game on Pre-assignment

2

Test on Standard

3

Review Test

4

Review 21 CFR 820 & Exercise

5

AU Module – Part 1. Intro to Auditing

6

Test on Part 1 / Review Test

7

Part 2. Preparing for an Audit

Day 3

1

Test on Part 2 / Review Test

2

Part 3. Conducting the Audit

3

Test on Part 3 / Review Test

4

Audit Role Play Exercise 1

5

Part 4. Completing the Audit

6

Test on Part 4 / Review Test

7

Exercise: Writing Audit Findings

3-day In Vitro Diagnostic Regulation 2017/746

For Medical Device Manufacturers

 

3 Day Schedule: 7:30 AM- 4:30 PM MST
CEU Hours: 2.5
Audience: Beginner to Advanced

The European Regulation 2017/746 related to In Vitro Diagnostic Devices (IVDR) is in effect and companies must make the transition to the new regulation by May 26, 2022.

Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. There are no grandfathering provisions, so it is time to help your organization understand this regulation. 

Overview

A three-day course on the In Vitro Diagnostic Regulation 2017/746 with a focus on the requirements for Medical Device Manufacturers.

In this course, you will receive a general overview of the IVDR, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.

Included in the presentation is a copy of the IVDR, an IVDR gap analysis template, a General Safety and Performance Requirements (GSPR) checklist, and a Technical Documentation Checklist.

Who Should Attend

Individuals who will perform audits to IVDR regulation or Quality\Regulatory Management Systems, individuals assisting their organizations toward IVDR compliance, or individuals who are frequently audited should attend this training. Quality/Regulatory directors, Quality/Regulatory managers, design & process engineers, auditors, ISO coordinators, laboratory professionals, risk managers, and manufacturing managers/supervisors will benefit from this training.

Objectives

  • Outline the primary changes that need to be addressed to Transition from IVDD compliance to IVDR compliance
  • Practical guidance on how to address the new IVDR requirements
  • Describe/Understand the objectives, terminology and structure of the IVDR.
  • Understand the additional Technical Documentation requirements compared to the Technical File and Design Dossier
  • Explain the impact of the new IVDR requirements on economic operators (importers, authorized representatives) including manufacturers.
  • Describe the different regulatory requirements through lifecycle of device, e.g. proof of concept, design and development, clinical evaluation, regulatory approval, manufacturing, postmarket/vigilance & end of life.
  • Describe the increased requirements for risk management including risk benefit and state of the art
  • Plan a gap assessment to transition an organization to compliance.
  • Understand how to prepare and complete a GSPR Checklist (compared to the Essential Requirements Checklist)
  • Identify the necessary step as to prepare an organization to transition to the IVDR.

Agenda

  • High level overview of the EU IVD Regulation
    1. Definitions
    2. Primary changes in the regulation and how to address them
  • Implementation timeline
  • Review of the 113 MDR Articles, the organization of the regulation and “how to find things”
  • Paths to CE Mark
  • Review of the 14 Annexes, their structure and “how to find things”
  • Lifecycle of a Medical Device and related Articles and Annex requirements
    1. Proof of Concept
    2. Design & Development
    3. Device Classification
    4. Design and Safety Requirements
    5. Risk Management
    6. Performance Evaluations
    7. Performance Studies
    8. Manufacturing requirements
      1. UDI requirements
    9. Conformity Assessments – Class A, B, C, D
    10. Technical Documentation
    11. Conformity Paths for – Class A, B, C, D
    12. Registration of Devices and Placing on the Market
    13. Post Market Surveillance and Vigilance
  • Review of Significant Articles
    1. In Depth Review and Discussion of Articles
  • Review of Significant Annexes
    1. In Depth Review and Discussion of Annexes
  • Strategy for Deployment
  • Significant Pitfalls to watch out for
  • Unknowns – Still to be determined
  • Tools and References

 

Quizzes, Tools, Workshops: Each day are ongoing quizzes to confirm your understanding of key concepts;  Review of helpful tools including:  EU MDR Gap Analysis Checklist, GSPR Conformity Checklist, Technical Documentation checklist, ISO 13485:2016 and ISO 14971:2019 checklist and comparison to the MDR requirements;  Further, there are workshops including:  Device Classification, Compliance Scenarios, and review of practical implementation examples.

 

This class is certified by Exemplar Global under their Exemplify process.  Accordingly, all students who attend the entire class, pass the quizzes, and demonstrate mastery of the workshops will receive a registered Certificate recognized by Exemplar Global.

3-Day EU Medical Device Regulation 2017/745

For Medical Device Manufacturers

 

3 Day Schedule: 7:30 AM- 4:30 PM MST
CEU Hours: 2.5
Audience: Beginner to Advanced

Overview  

Three-day course on the Medical Device Regulation 2017/745 with a focus on the requirements for Medical Device Manufacturers.

In this course you will receive a general overview of the Medical Device Regulation, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.

Included in the presentation is a copy of the MDR, an MDR gap analysis template, and a General Safety and Performance Requirements (GSPR) checklist with highlights of significant differences from the MDD Annex I Essential Requirements Checklist.

Who Should Attend

Individuals who will perform audits to MDR regulation or Quality\Regulatory Management Systems, individuals assisting their organizations toward MDR compliance, or individuals who are frequently audited should attend this training. Quality/Regulatory directors, Quality/Regulatory managers, design & process engineers, auditors, ISO coordinators, laboratory professionals, risk managers, and manufacturing managers/supervisors will benefit from this training.

Objectives

  • Outline the primary changes that need to be addressed to Transition from MDD/AIMD compliance to MDR compliance
  • Practical guidance on how to address the new MDR requirements
  • Describe/Understand the objectives, terminology and structure of the MDR.
  • Understand the additional Technical Documentation requirements compared to the Technical File and Design Dossier
  • Explain the impact of the new MDR requirements on economic operators (importers, authorized representatives) including manufacturers.
  • Describe the different regulatory requirements through lifecycle of device, e.g. proof of concept, design and development, clinical evaluation, regulatory approval, manufacturing, postmarket/vigilance & end of life.
  • Describe the increased requirements for risk management including risk benefit and state of the art
  • Plan a gap assessment to transition an organization to compliance.
  • Understand how to prepare and complete a GSPR Checklist (compared to the Essential Requirements Checklist)
  • Identify the necessary step as to prepare an organization to transition to the MDR.

Agenda

  • High level overview of the EU MDR Regulation
    1. Definitions
    2. Primary changes in the regulation and how to address them
  • Implementation timeline
  • Review of the 123 MDR Articles, the organization of the regulation and “how to find things”
  • Paths to CE Mark
  • Review of the 178 Annexes, their structure and “how to find things”
  • Lifecycle of a Medical Device and related Articles and Annex requirements
    1. Proof of Concept
    2. Design & Development
    3. Device Classification
    4. Design and Safety Requirements
    5. Risk Management
    6. Clinical Evaluations
    7. Clinical Investigations
    8. Manufacturing requirements
      1. UDI requirements
    9. Conformity Assessments – Class I, IIa, IIb, III
    10. Technical Documentation
    11. Conformity Paths for – Class I, IIa, IIb, III
    12. Registration of Devices and Placing on the Market
    13. Post Market Surveillance and Vigilance
  • Review of Significant Articles
    1. In Depth Review and Discussion of Articles
  • Review of Significant Annexes
    1. In Depth Review and Discussion of Annexes
  • Strategy for Deployment
  • Significant Pitfalls to watch out for
  • Unknowns – Still to be determined
  • Tools and References

 

Quizzes, Tools, Workshops:  Each day are ongoing quizzes to confirm your understanding of key concepts;  Review of helpful Tools including:  EU MDR Gap Analysis Checklist, GSPR Conformity Checklist, Technical Documentation checklist, ISO 13485:2016 and ISO 14941:2012 checklist and comparison to the MDR requirements;  Further, there are Workshops including:  Device Classification, Compliance Scenarios, and review of practical implementation examples.

 

Course Certification

This class is certified by Exemplar Global under their Exemplify process.  Accordingly, all students who attend the entire class, pass the quizzes, and demonstrate mastery of the workshops will receive a registered Certificate recognized by Exemplar Global.

 

2-Day Statistical Process Control (SPC)

Days: 2

Time:  7:30 AM- 4:30 PM MST

AXEON’s training courses begin with your objectives in mind. Before any training begins the instructor must have an objective to deliver your desired outcome. If the course does not have a specific objective, students can go through the motions with little added value. AXEON’s course setup begins with a candid discussion of your needs and expectations with the course instructor to develop specific areas of focus for the class. Below is a general outline for the course and topics that will be covered.

Overview

Statistical process control (SPC) procedures help you monitor process behavior. One of the staple SPC tools used by quality process analysts, improvement associates, inspectors and more is the control chart. Axeon’s statistical process control training will walk you through the details of control charting and other SPC procedures and how to apply them within your organization.

Who Should Attend?

·    Quality & Process Engineers ·    Process Development & Validation Personnel
·    Quality Technicians ·     Manufacturing/Operations Personnel
·    Production Supervisors ·    Process Improvement Personnel
·    SPC Supervisors ·    Supplier Quality Personnel
·    Laboratory Personnel ·    Six Sigma Professionals

 

Agenda

  • Sources of Variation
    • Common and Special Cause Sources
    • Detecting Special Cause Sources
  • Charts: Xbar and R
    • Differences Between Measurements and Averages
    • Computing Control Limits and Charting
  • Other Charts
    • Individuals & Moving Ranges
    • Xbar and S Charts
    • Charts for Short Production Runs
  • Attribute Charts (p, np, c, u)
    Chart Interpretation

    • Type I and Type II Errors
    • Guidelines for Analysis of Charts
    • Out of Control Signals
  • Sensitivity
    • Impact of Sample Size on Chart Sensitivity
    • Determining Sample Size
  • Process Capability
    • Capability ratio – Cr
    • Performance Ratio – Pr
    • Capability Index – Cp
    • Performance Index – Pp
    • Process Capability – CpK
    • The Standard Normal
    • Z Values
    • Computing Proportion Defective

2-day ISO 14971:2019

Application of risk management to medical devices

 

Overview

This class will teach participants to turn Risk Assessment into a well-organized systematic approach that targets and then reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Medical Device Manufacturers, these same techniques can be used regardless of the products or services offered by your organization.

Who Should Attend?

  • Anyone who needs to develop and implement a comprehensive Risk Management
  • Program meets requirements for ISO 14971
  • Any organization that needs a formal, disciplined approach to the identification, assessment and management of Risk
  • Quality Managers
  • Engineering Managers
  • Internal and external auditors
  • Design Teams
  • Management Representatives
  • Project Teams
  • Anyone who needs to understand the difference between Risk Identification, Risk
  • Assessment and Risk Management and how to put these important tools to work for your organization.

 

Course Objectives

  • The components of risk management that can be applied to any organization, regardless of their products or customers
  • How to design a risk management structure for your organization that gets results
  • A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed
  • Tools used for Risk Assessment such as FMEA and FMECA
  • How to quantify risk as the first step in establishing priorities for your organization

 

Agenda

Day 1 

  • Risk terminology and theory from ISO 14971,ISO 13485
  • History of risk management and relationship with Corrective and Preventive Actions
  • Requirements of ISO 14971
  • Design of framework for managing risk
  • 4.3.2 Establishing risk management policy
  • Integration into organizational processes
  • Establishing internal communication and reporting mechanisms
  • Establishing external communication and reporting mechanisms
  • Implementing risk management
  • Implementing the framework for managing risk & risk management process
  • Continual improvement of the framework
  • Communication and consultation
  • Establishing the internal and external context
  • Establishing the context of the risk management process
  • Defining risk criteria
  • Risk assessment
  • Risk identification
  • Risk analysis
  • Risk evaluation
  • Risk treatment
  • Selection of risk treatment options
  • Preparing and implementing risk treatment plans
  • Monitoring and review
  • Recording the risk management process
  • Exercises B.1 – B.6 internal & external framework, risk treatment, risk monitoring, risk policy, risk analysis

Day 2

  • Guidelines from ISO 14971
  • Techniques – Risk Management
  • Selection of risk assessment techniques
  • Selection of techniques
  • Availability of Resources
  • The Nature and Degree of Uncertainty
  • Complexity of risk
  • Application of risk assessment during life cycle phases
  • Types of risk assessment techniques
  • Flow charts and process mapping
  • Brainstorming
  • Risk Checklists
  • Delphi Method
  • Process FMEA
  • Design FMEA
  • Fault Tree Analysis (Event Tree Analysis)
  • HAZOP & HACCP
  • Cause & Effect with 5-Whys & 7-M
  • Preliminary hazard analysis
  • Risk Ranking and Filtering
  • Case Studies with application
  • Organization’s Risk Procedures and Tools
  • Case Studies from Organization’s Risk Analysis, Treatment and Monitoring
  • Risk Applications in the Aerospace organization
  • Internal Audit
  • Training
  • CAPA System
  • Supplier Selection & Control
  • Outsourcing – Special Processes
  • Facilities and Equipment
  • Design & Development
  • Production and Process Controls
  • Process Validation and Re-Validation
  • Servicing
  • Design FMEA Case Study
  • Various Risk Case Studies
  • Organization’s Case Studies
  • Statistical Methods
  • Test

 

Human Factors

And How to Address Them

Days: 2

Time: 7:30 AM- 4:30 PM MST

Audience: Beginner to Advanced

Overview

Human Factors is a term that appears in the latest versions of several ISO standards, including:

  • ISO 9001:2015 General manufacturing QMS
  • AS9100D:2016  Aerospace QMS
  • ISO 14971:2007 Risk management for medical devices
  • ISO 45001:2018 Occupational health and safety

This course helps you to understand human factors in the context of each standard.  You will learn how to apply the concept of human factors to your management system and address the standard requirements.  You will also receive practical tools, proven methodologies, and helpful tips to make the job easier for you.

As with all of Axeon’s courses, this is a practical, how-to course that is not bogged down in academic discussions.  We use case studies, practice exercises, and learning activities to keep the training activities and build competence.

Who Should Attend?

·     Quality managers Also:
·     Management representatives ·     Quality consultants
·     Quality engineers ·     Those involved in performing corrective actions
·     Safety managers ·     Those involved in medical device risk management
·     Top management ·     Preparation Of Checklists From Process Analysis
·     Regulatory affairs specialists

 

Prerequisites

 

None.  Our students range from seasoned quality professionals to novices. Our goal is to meet everyone at their current level of competence and increase it.

Course Objectives

  • Understand the requirements of human factors in the context of each standard.
  • Learn how to address human factors within your organization’s quality and/or safety management system.
  • Provide practical tools and methods for addressing human factors.

 

Agenda

 

Day 1 

Intro to Human Factors
Review ISO Standard Requirements: 9001, AS9100D, 14971, 45001
Definitions of Human Factors by Standard

Human Factors and Root Cause Analysis
Corrective Action and Human Factors
The 13 Most Common Human Factors
Activity: Applying Human Factors in Corrective Action

Human Factors and Poka-Yoke
Definition & History of Poka-Yoke
Methodology for Poka-Yoke
Activity: Applying Poka-Yoke to Human Factors

Day 2

Human Factors and Health & Safety
Definition of Human Factors in Health & Safety
Human Factors and Ergonomics
How Human Factors influence Safety at Work
Activity: Applying Human Factors to Safety

Human Factors and Medical Devices
Methodology for Considering Human Factors in Risk Assessment
Device Design According to Human Factors Consideration
Human Factors in Post-Market Surveillance

Final Test

Maximizing the ROI from your Quality Management System

Days: 1

Time: 7:30 AM-4:30 PM MST

Audience: Top management

Overview 

A Quality Management System is NOT a cost of doing business.  It’s an investment.  And top management should expect to get a financial return on that investment.  However, the Return On Investment (ROI) they receive will be greatly impacted by the level of leadership and commitment they provide concerning the management system.

The newest versions of most ISO management standards have amplified the requirements for top management, in accordance with ISO 9001:2015.  In this highly interactive course, senior managers will learn how to fulfill their new responsibilities, take accountability, and maximize the ROI they get from their management systems.

Why Attend?

This class will help to show the true value of your quality management system and how much it really adds to your bottom line. It will also help your company to increase the ROI of your QMS.

If you want to improve your company’s bottom line or show your boss how much your QMS is already contributing to profits then this class is for you.

Who Should Attend?

  • Top management from organizations with quality, environmental, or safety management systems, including chief executives, general managers, and other senior managers.
  • Quality Managers and/or Management Representatives
  •  Anyone considering implementing an ISO quality system

Course Objectives

  • Understand the new top management ISO requirements and how to accomplish them.
  • Understand the responsibilities that can be delegated to a management representative, and those responsibilities top management must retain.
  • Learn how to maximize the ROI from your management system.
  • Receive practical methods, tools, and tips for using your QMS to enhance organizational performance.
  • Learn the mistakes to avoid that can negatively impact your management system.
  • To provide decision-makers with information that will help them to provide direction for their existing or planned quality management system

 

Agenda

Benefits of a Quality Management System

  • Overview of Potential Benefits, including Return on Investment (ROI)
  • Why Top Management Leadership and Commitment is Important.
  • Creating an Organizational Culture that Supports Quality.

Overview of Quality Principles

  • What is Quality?  What is Quality Management?
  • Top Management Responsibilities (per ISO 9001) and How to Accomplish Them.

How to Maximize the ROI from your QMS

  • ROI Depends on an Organization’s Level of Commitment to its QMS System.
  • Using your QMS processes to ensure Customer Satisfaction and Increase Profitability.
  • Using the Process Approach to Manage Quality (Turtle Diagram).
  • Establishing KPIs and Determining Process Effectiveness.
  • Continuously Improving your QMS.
  • Reducing the Costs of Poor Quality (COPQ).
  • Using Your QMS to Manage Risks and Support Your Strategic Direction.

 

The Five Biggest Mistakes Executives Make with Quality Management

 

Final Test