ISO 13485 Lead Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 5:30 PM MST

Who Should Attend Quality Managers Management Representatives Audit Program Managers Lead Auditor Candidates Those involved in designing a QMS for their organizations Internal Auditors Quality Consultants Top Management Managers who are audited in QMS audits Those who perform supplier audits Those who perform third-party (ISO certification) audits Anyone looking to improve their organization’s quality management system

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider. Attendees successfully completing the examinations provided in conjunction with this ISO 13485 lead auditor training course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: MD – Medical Devices Management Systems AU – Auditing Management Systems TL – Leading Management Systems Audit Teams

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

ISO 13485 Lead Auditor Training Objectives 

1. Develop the knowledge and skills required to become a Lead Auditor.
2. Improve your understanding of the international standard and 21 CFR 820.
3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
4. Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

Related Courses

In-Person ISO 13485 Lead Auditor Training	cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training	Medical Device Single Audit Program (MDSAP) Training	EU Medical Device Regulation (EU MDR) Training

ISO 13485 Lead Auditor Training (In-Person)

 Recognized by Exemplar Global

Days: 4 • CEU Hours: 3.2

 7:30 AM – 5:30 PM MST

Who Should Attend Quality Managers Management Representatives Audit Program Managers Lead Auditor Candidates Those involved in designing a QMS for their organizations Internal Auditors Quality Consultants Top Management Managers who are audited in QMS audits Those who perform supplier audits Those who perform third-party (ISO certification) audits Anyone looking to improve their organization’s quality management system

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider. Attendees successfully completing the examinations provided in conjunction with this ISO 13485 lead auditor training course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: MD – Medical Devices Management Systems AU – Auditing Management Systems TL – Leading Management Systems Audit Teams

This course is recognized by Exemplar Global as meeting the knowledge requirements for ISO 13485 Lead Auditor Certification in Medical Device Quality Management Systems.

ISO 13485 Lead Auditor Training Objectives 

1. Develop the knowledge and skills required to become an ISO 13485 Lead Auditor.
2. Improve your understanding of the international standard and 21 CFR 820.
3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
4. Fulfill the education requirements of the Exemplar Global Certified Lead Auditor program.

Agenda

Related Courses

Live-Online ISO 13485 Lead Auditor Training	cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training	Medical Device Single Audit Program (MDSAP) Training	EU Medical Device Regulation (EU MDR) Training

ISO 13485 Course for Internal Auditor Training (Live-Online)

 Recognized by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 5:30 PM MST

Who Should Attend Quality Managers Management Representatives Audit Program Managers Those involved in designing a QMS for their organizations Internal Auditors Quality Consultants Top Management Managers who are audited in QMS audits Those who perform supplier audits Those who perform third-party (ISO certification) audits Anyone looking to improve their organization’s quality management system

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider. Attendees successfully completing the examinations provided in conjunction with this ISO 13485 course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: MD – Medical Devices Management Systems AU – Auditing Management Systems

This ISO 13485 course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

ISO 13485 Course Objectives 

1. Develop the knowledge and skills required to become an Internal Auditor.
2. Improve your understanding of the international standard and 21 CFR 820.
3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
4. Fulfill the education requirements of the Exemplar Global Certified Internal Auditor program.

Agenda

Related Courses

ISO 13485 Lead Auditor Training	cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training	Medical Device Single Audit Program (MDSAP) Training	EU Medical Device Regulation (EU MDR) Training

ISO 13485 Internal Auditor Training (In-Person)

 Recognized by Exemplar Global

Days: 3 • CEU Hours: 2.4

 7:30 AM – 5:30 PM MST

Who Should Attend Quality Managers Management Representatives Audit Program Managers Those involved in designing a QMS for their organizations Internal Auditors Quality Consultants Top Management Managers who are audited in QMS audits Those who perform supplier audits Those who perform third-party (ISO certification) audits Anyone looking to improve their organization’s quality management system

Exemplar Global Certified Training Provider

Axeon is an Exemplar Global Certified Training Provider. Attendees successfully completing the examinations provided in conjunction with this ISO 13485 course receive a Certificate of Attainment for these Exemplar Global knowledge competency units: MD – Medical Devices Management Systems AU – Auditing Management Systems

This ISO 13485 course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

ISO 13485 Internal Auditor Objectives 

1. Develop the knowledge and skills required to become an Internal Auditor.
2. Improve your understanding of the international standard and 21 CFR 820.
3. Learn how to audit to the requirements of the Standard and to your own Standard Operating Procedures (SOPs).
4. Fulfill the education requirements of the Exemplar Global Certified Internal Auditor program.

Agenda

Related Courses

ISO 13485 Lead Auditor Training	cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training	Medical Device Single Audit Program (MDSAP) Training	EU Medical Device Regulation (EU MDR) Training

ISO 13485 Internal Auditor Training

Days: 2 • CEU Hours: 1.9

 Day 1: 7:30 AM – 5:30 PM MST

Day 2: 7:30 AM – 4:00 PM MST

Who Should Attend Quality directors Managers Engineers Auditors ISO coordinators Laboratory quality professionals Anyone engaged in quality audits or quality assurance for medical devices

ISO 13485 Internal Auditor Training Objectives

1. Prepare to conduct a solo internal audit at successful course completion.
2. Fully understand and interpret the ISO 13485:2016 requirements.
3. Apply the proper interpretation of the standard in actual audit situations.
4. Understand process auditing tools leading to substantive quality system improvements.
5. Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
6. Follow-up and resolve audit trails that present themselves during the audit interviews.
7. Conduct audits that result in real improvements to the quality system.
8. Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.
9. Compare ISO 13485 to FDA 21 CFR 820 and the new Rule QMSR overview.

Agenda

Related Courses

ISO 13485 Lead Auditor Training	cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training	MDSAP Training	ISO 9001 Lead Auditor Training

Days: 0.5

Time: 7:30 AM- 11:30 AM MST

Audience: Beginner to Advanced

Overview

This half-day training will train you on revisions to the FDA 21 CFR Part 820 Management System Regulations (QMSR) published in February 2024, especially related to the integration of ISO 13485:2016.

You’ll receive an understanding of the following:

• The FDA’s announcement on February 2, 2024 to integrate ISO 13485:2016 into the new 21 CFR 820 QMSR
• New implementation timeline
• Real examples of what’s new, and what is being removed or becoming obsolete
• Examples of what is still required by FDA regulations until February 2026
• The importance of getting started RIGHT NOW to create the Quality Manual, etc.
• Medical Device Single Audit Model (MDSAP) and how impactful it can be to the QMS and audit program

Who Should Attend

• ALL companies who make a medical device regulated by the FDA (Class I, II and III)
• Top/Senior Management – Strategic Planners
• Regulatory Management – Strategic AND Tactical Planners
• Regulatory Associates – Tactical – “Doers” of the work
• Marketing Management – Strategic Planners and Post-Market Surveillance
• Quality Managers and Associates
• Auditors: Internal & 3rd Party external auditors
• Consultants advising clients on making the upgrades to the new QMSR
• Design and Development Engineers and Management
• Product Risk Managers

Objectives

• Understand the primary changes from QSR to the QMSR
• Understand the importance of creating a Quality Plan to effectively plan for the changes
• Identify the necessary steps as to prepare an organization to transition to the QMSR requirement
• The importance of MDSAP

Agenda

1. High-level overview of the planned QMSR changes
2. In-depth review of the planned QMSR changes
3. Implementation timeline
4. Strategy for deployment so the company’s QMS complies to the new QMSR regulation
5. The importance of MDSAP
6. Connecting with the appropriate Notified Body or Certification Body

Course Certificate

Participants will receive a cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation training certificate.

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 EU MDR, 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.

EU MDR Training 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.

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

MDSAP Training 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.

Application of Risk Management to Medical Devices

2-Day Schedule: 7:30 AM – 4:30 PM MST   Audience: Beginner to Advanced

ISO 14971 Training 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 learned in this ISO 14971 training 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 14971:2019 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.

 

Agenda

Day 1 

• 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

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 for Medical Devices

• 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

Days: 2 

 7:30 AM- 4:30 PM MST

Learn CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals

Come learn the FDA 21 CFR and ISO 13485 requirements for a regulatory-compliant CAPA system and records. You will leave this training knowing how to perform effective root cause investigations that address, resolve, and prevent the issue(s) from recurring. This same CAPA methodology can be used to address Regulatory audit findings throughout the world.

This course teaches:

✔ The regulatory requirements for pharmaceutical and medical device CAPA:

• 21 CFR Part 4 – Good Manufacturing Practices for Combination Products
• 21 CFR Part 820 – Quality System Regulations for Medical Devices; Good Manufacturing Practices for Devices
• 21 CFR Part 801 – Labeling of Medical Devices
• 21 CFR Part 201 – Labeling of Drugs
• 21 CFR Part 210 and 211 – Good Manufacturing Practices in Manufacturing, Processing, Packing or Holding Drugs
• ISO 13485:2016 – Quality System Requirements for Medical Devices (and comparison to MDSAP and EU MDR/IVDR requirements)
• EU MDR CAPA Requirements related to: Article 83 PMS, Article 10 Manufacturing, Article 89 Serious Incidents

✔ How to perform effective fast-paced root cause analysis and complaint investigations– no more “best-guesses”

✔ How to document complaint investigations and maintain records to demonstrate compliance

✔ Root cause investigation methods, such as: The 5 Whys: Including 5-Whys Tree and 3×5 Whys (or 3-legged 5-Whys) Fault Tree Analysis Cause and Effect Flow Charting Pareto Charting Fish-bone/6 M approach (Man, Method, Machine, Material, Milieu (Measurement & Mother Earth)

✔ Other helpful pharma & medical device CAPA Tools including:

• 5-W 2-H and 5-W 2-H Proof
• FMEA
• Containment approaches
• Incident Risk Analysis
• Paynter Charts
• Layered Process Auditing
• Corrective Action Plans
• COPQ approach to CAPA profit enhancement

Learning Objectives:

1. Learn and practice within a compliant corrective action & preventive action (CAPA) process.
2. Learn how to perform effective root cause investigations.
3. Learn and understand when and how to apply the appropriate root cause investigation tool/method.
4. Learn and understand which records are required to demonstrate compliance to the FDA’s CFR Part 4 and CFR Part 820 regulations and ISO 13485 requirements.
5. How to establish effective corrective action plans.
6. How to plan & perform a Verification of Effectiveness (VoE) to assess if the corrective actions resolved the root of the problem.
7. Learn how to keep the CAPA process SIMPLE, effective, and adding value while reducing costs.
8. Learn how CAPA and Kaizen Events (Proactive) work together to demonstrate compliance.
9. Learn the interrelationships between: Nonconformities, Complaints, Post Market Surveillance and QMS monitoring and statistical techniques

Who Should Attend

• Do you do Corrective Actions? – THEN YOU SHOULD ATTEND!
• Quality Engineers (QE)
• Manufacturing Engineering (ME)
• Process Engineers & Technicians
• Electrical Engineers (EE) and Technicians
• Top Management – Why? They are ultimately responsible for ensuring the CAPA system is working effectively.
• Operations Directors & Management
• Engineering Directors & Management
• Marketing Directors & Management
• Manufacturing Directors & Management
• Regulatory Directors & Management
• Quality Assurance Directors & Management
• Purchasing Managers
• Supply Chain Managers who deal with SCAR and CAR processes.
• ANYONE WHO THINKS THEY KNOW MEDICAL DEVICE CAPA but really doesn’t get it, making them a prime target for a HUGE FDA finding that will ROCK their world and WASTE ALL SORTS of time and resources.

Class Agenda

Day 1

• Overview – Why CAPAs are required
  • Overview of the Regulatory requirements for CAPA in the following countries:
  • USA (FDA)
  • Australia (TGA)
  • Brazil (ANVISA)
  • Canada (CMDR)
  • Japan (PMDA)
  • European Union (including BREXIT)
• Typical Problems with Root Cause Investigations
  • Why most problem-solving models don’t get to the root cause and a solution
  • How analytical and creative thinking must be both separated and integrated
  • Difference between content and process thinking
• Responsibilities for Root Cause and Corrective/ Preventive Action
  • Top Management, Operation Management, Marketing Management, Engineering, Quality, Design, Frontline Management, Supervisors, Worker
• Step 1: Assigning a corrective action team leader: cross functional team
• Step 2: Describing the problem – COPQ
  • Activity – Risk Ranking for Quality Events – Deciding: Proportionate to the Effects
  • Activity – Medical Device CAPA Case Study #1: What constitutes an effective CAPA?
  • Activity – Detailed problem descriptions
• Step 3: Containing the problem
  • Case Study – CAPA Case Study #2: What is proper Containment of the problem?
• Step 4: Identifying the root cause or causes
  • System, process, & product causes
  • Root cause/data investigation tools (flow charts, histograms, Pareto charts, Paynter charts, control charts, run charts, etc.)
• Data Collection and Analysis
  • Check sheets, graphs, and tables for discrete data collection
  • Surveys, interviews, and field observation for opinions or less precise data
  • Activity – “5 Whys” method, 3×5 Whys, 5-Whys Tree
  • Activity – Ishikawa or Cause & Effect Diagram

Day 2

• Step 5: Verifying the root cause or causes
  • Activity: Likely Cause Worksheet: CAPA Case Study #2
  • Activity: 5-W 2-H Proof: CAPA Case Study #2
  • Pareto or 80/20 Rule, I can’t work EVERY cause, which ones?
• Step 6: Implementing corrective actions
  • Band-Aids vs Long-Term improvement: ST, IT and LT Corrective Actions
  • Corrective Action Plans: managing resources and achieving permanent improvement
• Step 6a: Risk Assessment: verify CAPA does not impact regulatory or safety requirements
  • Risk Management Process: ISO 14971 MD application of Risk Management
  • Hazards, Hazardous Situations and Harms – keeping your device Safe and Effective
  • Determining Probability of a Hazardous Situation presenting itself (P1), and of a Harm resulting (P2)
  • Activity: FMEA for CAPA Case Study #2
• Step 7: Verifying corrective action effectiveness
  • Production Process Audits: are proactive controls In-Place
  • Layered Process Auditing: Effecting permanent Change in your Organization
  • Crafting Effectiveness Check plans for each Corrective Action
  • Activity: Effectiveness Plan: CAPA Case Study #2
  • Paynter Charting: temporary Effectiveness Check
• Step 8: Closing the Corrective Action – Finally ALL DONE
  • Considering Preventive Actions:
    • Preventive vs. Corrective Actions: FDA and Final Rule FDA 820 Considerations
    • FMEAs – it’s all Preventive or Proactive
    • 3×5 Whys and “Read Across”
  • Congratulate the TEAM!
• Course Insights and Final Exam

3 Day Schedule: 7:30 AM – 4:30 PM MST   Audience: Beginner to Advanced

Overview

Our process and 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 process and software 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.

Process and Software Validation Training 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 in 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:
    • Validation Team
    • 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. 1. 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

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!

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.

IVDR Training 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.

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 Statistical Process Control training 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?

Statistical Process Control Training Agenda

• Fundamentals of SPC
  • Concept of Variation
  • The Normal Distribution
  • Control Limits vs. Specification Limits
  • Definition of Control/Stability
  • Definition of Quality
  • Quality Control vs. Process Control
• Fundamental Statistical Concepts
  • Population versus Sample
  • Notation
  • Measures of Central Tendency (Mean, Mean)
  • Measures of Variation (Range, Standard Deviation, Variance)
  • A Central Limit Theorem
  • Introduction to Non-Normal Data
  • The Central Limit Theorem
• Conceptual Implementation of SPC
  • Measurement Systems Issues
  • Monitoring Process Behavior
  • Xbar and R Chart Concepts
• Sampling
  • Random, Systematic, and Rational Samples
  • Importance of Rational Sampling
• 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

Days: 2 • CEU Hrs: 1.9
Time: 7:30 AM – 4:30 PM
Audience: Beginner to Advanced

Supplier Audit Training Overview

This course prepares you to perform supplier audits using industry-proven techniques and to apply proper interpretation of the ISO standards 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 Supplier Auditor class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing. 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 supplier audits to supplier requirements, ISO Standards and/or Quality Management Systems.

Prerequisites

There are no required prerequisites. This course is routinely taught to quality novices and lifetime professionals.

Agenda

Day 1

Day 2

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 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.

Who Should Attend our Human Factors Online Training?

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

Days: 1

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

Audience: Top management

Overview 

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.

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