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.
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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.
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.
| · 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 |
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.
| 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 |
If you have a Discount Code, Enter it in the Field below and press "Apply Discount Code" button to get Discount.
Actual Price: $
|
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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.
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.
| · 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 |
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.
| 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 |
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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.
Group Exercises: Validation vs. Verification; Process Capability; Validation Master Plan;
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
Individual Exercise: In-Class Log In Page; Prepping for an OQ; Review OQ Case; Prepping for PQ; COTS Software Testing; V&V Traceability Matrix
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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.
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.
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.
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Actual Price: $
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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.
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.
| · 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 |
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.
| 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 |
If you have a Discount Code, Enter it in the Field below and press "Apply Discount Code" button to get Discount.
Actual Price: $
|
|
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.
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.
| · 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 |
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.
| 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 |
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The European Regulation 2017/746 related to In Vitro Diagnostic Devices (IVDR) is in effect and companies must make the transition!
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.
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.
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.
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.
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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.
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.
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.
If you have a Discount Code, Enter it in the Field below and press "Apply Discount Code" button to get Discount.
Actual Price: $
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.
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.
| · 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 |
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In this course, you’ll learn how to use a simple 8-step approach to correcting and preventing problems or nonconformities that exist anywhere in their organization. It can help to satisfy quality management system requirements for planning and establishing a process for corrective action.
Learn the process for completing a formal corrective action request. You’ll learn how to describe a problem, conduct causal analysis and what information is needed in order to ensure a corrective action is complete and effective.
This corrective action training is a great course for anyone learning to deal with corrective actions for the first time or anyone who needs a refresher to calibrate your knowledge and build confidence in your abilities.
Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain an in depth understanding of the 8-step approach for CAPA’s.
Application of Closed-Loop Root Cause & Corrective/Preventive Action Tools
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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 learned in this ISO 14971 training can be used regardless of the products or services offered by your organization.
Who Should Attend?
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- Risk terminology and theory from ISO 14971 and 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
- 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
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Actual Price: $
Days: 2
Time: 7:30 AM- 4:30 PM MST
Audience: Beginner to Advanced
Human Factors is a term that appears in the latest versions of several ISO standards, including:
This Human Factors online training 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 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.
| · 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.
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
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
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Actual Price: $
Days: .5
Time: 7:30 AM- 11:30 AM MST
Audience: Beginner to Advanced
This half (1/2) day training will inform you on recent FDA 21 CFR 820 changes to Quality Management System Regulations (QMSR), especially related to the integration of ISO 13485:2016.
You’ll receive an understanding of the following:
Participants will receive a 21 CFR 820 & ISO 13485:2016 QMSR Training Certificate.
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Actual Price: $
Days: 1
Time: 7:30 AM-4:30 PM MST
Audience: Top management
A QMS (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.
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.
Benefits of a Quality Management System
Overview of Quality Principles
How to Maximize the ROI from your QMS
The Five Biggest Mistakes Executives Make with Quality Management
Final Test
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