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Medical Device Regulations- FDA 21 CFR 820 Register for course

The medical device industry is highly regulated due to the product risk to health. One of the regulated requirements is to establish and maintain a quality management system . Although the rest of the world complies with ISO 13485 standard, the United States requires compliance to the 21 CFR 820, Quality System Regulation (QSR). The QSR, specifying current Good Manufacturing Practices (GMP) for medical devices, was established in 1997 based on earlier structure of the ISO 9001 and 13485. Understanding the QSR is essential to ensure compliance to the United States regulatory requirements and to prepare for an eventual visit from the FDA. OBJECTIVES This course will provide participants with the following: • Overview of the FDA and intention of the 21 CFR 820 • Up-to-date requirements of the 21 CFR 820 • Working knowledge in application to their organization • Ability to prepare and host an FDA inspection Course Length- 8 Modules Time to complete- 5-7 hours
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Live Online Courses Register for course

1-day ITAR Bascis Register for course

2-day ISO Internal Auditor Register for course

This training meets 2 times. Thu, Mar 31, 2016 7:30 AM - 4:30 PM MDT Fri, Apr 1, 2016 7:30 AM - 4:30 PM MDT
*******Live- Instructor Lead Virtual Class******* Overview: This course prepares you to perform internal ISO QMS audits using industry-proven techniques and to apply proper interpretation of the ISO standard 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 teaches Internal Auditing for ISO 9001, 13485, AS9100, TS 16949, and ISO 14001 Quality Management Systems. This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the ISO standard. 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 ISO 9001, 13485, AS9100, TS1649 and/or 14001 Standards or Quality Management Systems, individuals assisting their organizations toward ISO 9000 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. This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the ISO 9001, 13485, AS9100, TS16949, and/or 14001 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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4-day ISO 9001 Lead Auditor- Exemplar Global Certified Register for course

This training meets 4 times.Mon, Mar 21, 2016 7:30 AM - 4:30 PM MDT Tue, Mar 22, 2016 7:30 AM - 4:30 PM MDT Wed, Mar 23, 2016 7:30 AM - 4:30 PM MDT Thu, Mar 24, 2016 7:30 AM - 4:30 PM MDT
EXEMPLAR GLOBAL CERTIFIED- ISO 9001 QUALITY MANAGEMENT SYSTEMS LEAD AUDITOR COURSE We teach you how to use auditing to improve your organization Each 4-day class covers:  Quality management principles  Standards and guidelines (including history of standards)  Interpretation of the latest revision ISO 9001  Documentation and records  Introduction to quality audit  Managing the audit process  Audit scheduling and preparation  Performing the audit  Reporting the audit  Corrective action and follow-up  Registration, Accreditation and Auditor Certification The workshops include:  Analyzing Processes to Identify Resources and Critical Controls  Analyzing Operational Risk  Reviewing System Documentation and Preparing an Audit Plan  Reviewing Processes and Preparing Checklists  Verifying Facts  Determining Nonconformities  Writing Nonconformity Statements  Interviewing Auditees  Chairing a Closing Meeting  Reporting the Audit  Taking Corrective Action Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these Exemplar Global (RABQSA) knowledge competency units: QM – Quality Management Systems, AU – Auditing Management Systems and TL – Leading Management Systems Audit Teams. The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global (RABQSA International) for certification as a Quality Management Systems Lead Auditor. Even though ISO 9001 is used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard. This course is being held in conjunction with Quality Management International, Inc. (QMII) an Exemplar Global certified provider.
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4-day ISO 13485:2016 Lead Auditor- Exemplar Global Certified- with FDA 21 CFR 820 Register for course

This training meets 4 times.Mon, Mar 14, 2016 7:30 AM - 4:30 PM MDT Tue, Mar 15, 2016 7:30 AM - 4:30 PM MDT Wed, Mar 16, 2016 7:30 AM - 4:30 PM MDT Thu, Mar 17, 2016 7:30 AM - 4:30 PM MDT Mon, Apr 4, 2016 7:30 AM - 6:30 PM MDT
QUALITY MEDICAL DEVICE MANAGEMENT SYSTEMS LEAD AUDITOR WITH ISO 13485:2016 AND FDA 21 CFR 820 We teach you how to use auditing to improve your organization Each 4-day class covers:  Quality management principles  Standards and guidelines (including history of standards)  Interpretation of the latest revision ISO 9001  Interpretation of the latest revision ISO 13485  FDA 21 CFR 820  Documentation and records  Introduction to quality audit  Managing the audit process  Audit scheduling and preparation  Performing the audit  Reporting the audit  Corrective action and follow-up  Registration, Accreditation and Auditor Certification The workshops include:  Analyzing Processes to Identify Resources and Critical Controls  Analyzing Operational Risk  Reviewing System Documentation and Preparing an Audit Plan  Reviewing Processes and Preparing Checklists  Verifying Facts  Determining Nonconformities  Writing Nonconformity Statements  Interviewing Auditees  Chairing a Closing Meeting  Reporting the Audit  Taking Corrective Action Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these EXEMPLAR GLOBAL knowledge competency units: MD – Medical Device Management Systems, AU – Auditing Management Systems and TL – Leading Management Systems Audit Teams. The Certificate of Attainment provides evidence of knowledge competency defined by EXEMPLAR GLOBAL for certification as a Medical Device Management Systems Lead Auditor. Even though ISO 9001 and ISO 13485 are used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard. This course is being held in conjunction with Quality Management International, Inc. (QMII) an Exemplar Global certified provider.
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2-Day Root Cause Analysis, Corrective Action and Preventive Action Register for course

This training meets 2 times. Mon, Mar 28, 2016 7:30 AM - 4:30 PM MDT Tue, Mar 29, 2016 7:30 AM - 4:30 PM MDT Mon, Apr 25, 2016 7:30 AM - 6:30 PM MDT
*******Live- Instructor Lead Virtual Class******* Description: This course teaches attendees 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. Learning Objectives: 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. A great course for anyone learning to deal with corrective actions for the first time or if you just need a refresher to calibrate your knowledge and build more confidence in your abilities. Who Should Attend: 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.
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2-day Quality Risk Management Principles and Practices Register for course

Wed, Mar 30, 2016 7:30 AM - 4:30 PM MDT Thu, Mar 31, 2016 7:30 AM - 4:30 PM MDT Wed, Apr 27, 2016 7:30 AM - 6:30 PM MDT
*******Live- Instructor Lead Virtual Class******* Description: 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 Aerospace and 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 31000 and 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. What you will learn + Risk-Based Thinking and Actions required in the new ISO 9001-DIS 2014 per ISO 31000 + 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
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1-Day Transition for ISO 9001:2015, ISO 13485:2016 & AS9100:2016 Register for course

Fri, Apr 1, 2016 7:30 AM - 6:30 PM MDT
*******Live- Instructor Lead Virtual Class******* Who Should Attend: Those responsible for planning and executing the transition from ISO 9001:2008 to ISO 9001:2015, including Management Representatives and Quality Managers, or anyone desiring an up-to-date awareness of the changes that will be impacting new or existing ISO 9001:2008-based Quality Management Systems, including ISO 13485 and AS9100. Course Objectives:
  • Fully understand and interpret the relevant appendices of Annex SL, with their implications
  • Receive tools, techniques and tips to address the strategic planning elements of Annex SL
  • Become aware of changes to Preventive Action, and basic risk-management concepts and tools
  • See how the new format and structure of the 2015 sub-clauses compares to those of 2008
  • Become aware of potential changes in documentation and other requirements
  • Understand key changes for ISO 13485:2016 and ISO 9001:2015
  • Understand key changes proposed for AS9100
  • Plan and schedule needed internal changes on a Transition Road Map
  • Provide critical knowledge for your management and staff regarding the evolution of ISO 9001 and ISO 13485
Agenda: Day One
  • New Requirement of ISO 9001:2015, ISO 13485:2016, and AS9100:2016
  • Highpoints of the new requirements proposed for AS9100
  • Major Milestones completed to date
  • Schedule Leading to Final Publication of AS9100 Rev D
  • Introduction to Annex SL, 2012
  • Implications of Appendix 2
  • Comparison of the Structure and Sequence of ISO 9001:2015 to ISO 9001:2008
  • Implications of Appendix 4
  • Strategic Planning Elements of 4.1, 4.2, 6.1, and 9.3
  • Risk-based Elements of 6.1, 7.5.1, and 8.1
  • Action Plan Elements of 6.2
  • Likely Differences in Documentation and Other Requirements
  • Timetable for Transition of Certification to ISO 9001:2015, ISO 13485:2015, and AS9100:2016
  • Individualized Transition Road Map
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