TRAINING CATALOG WINTER SPRING 2018

Transcription

1 Years of Excellence TRAINING CATALOG WINTER SPRING 2018 Transition Courses NEW! Transition to the New EU Medical Device Regulation (MDR) NEW! Transition to the Medical Device Single Audit Program (MDSAP) UPDATED! Transition to ISO 13485: ISO Auditor Courses Foundation Courses Internal Auditor Training for ISO Lead Auditor Training for ISO UPDATED! Quality Systems for Medical Devices: FDA s QSR and ISO 13485: UPDATED! Developing and Maintaining a GMP/ISO-Compliant Document Management System Focused Skills Courses MEDICAL DEVICE RA/QA Implementing Design Control Requirements and Best Practices Risk Management for Medical Devices: ISO UPDATED! Complaint Handling, Vigilance Reporting, and Recall Management UPDATED! Software Verification and Validation Requirements Optimizing CAPA Programs for the Medical Device Industry Root Cause Analysis for Life Science Investigations Medical Device Product Submissions in the US and EU Supplier Quality Management: Designing a Successful Program Process Validation Principles and Protocols NEW! Performance-Based Auditing: A Tool for FDA s Case for Quality ISO 9001 Faculty Lead Auditor Training for ISO Internal Auditor Training for ISO Transition to ISO 9001: Risk Management for ISO 9001: Instructor Spotlight ORIELSTAT.COM info@orielstat.com

2 ! Multiple transition deadlines demand timely action from medical device manufacturers. Deadlines for ISO 9001:2015 (page 13), MDSAP (page 4), and ISO 13485:2016 (page 5) are fast approaching, and the deadline for the new EU Medical Device Regulation (page 3) isn t far behind. Get prepared with training and consulting support from Oriel STAT A MATRIX. KEY TRANSITION DATES September 14, 2018 ISO 9001:2008 certifications no longer valid. ISO 9001 : 2015 November 30, 2018 Upgrade audit should be complete. February 28, 2019 ISO 13485:2003 certifications no longer valid. ISO : 2016 January 1, 2019 CMDCAS certificates no longer valid. MDSAP May 26, 2020 MDR compliance required for all new devices or recertification. May 27, 2022 MDD Annex IV certificates expire. May 26, 2024 All other MDD certificates expire. EU MEDICAL DEVICE REGULATION (MDR) May 27, 2022 IVDR compliance required for all new devices or recertification. May 26, 2025 All other IVDD certificates expire. EU IN VITRO DEVICE REGULATION (IVDR) TRAINING IS STEP 1. Next, you need to understand your gaps and develop a plan to move forward. Oriel STAT A MATRIX s industry experts can help. Contact us at info@orielstat.com or to learn more.

3 PGE HEAD NEW! Transition to the New EU Medical Device Regulation (MDR) MEDICAL DEVICE RA/QA NEW EU Device Regulations New quality system requirements, classification rules, and conformity assessment procedures these are just a few of the hurdles that manufacturers must clear to sell their devices in the European Union (EU) now that the new Medical Device Regulation has been published. The new European Union Medical Device Regulation (MDR 2017/745) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the May 26, 2020 transition deadline. This course is a critical first step. Over 2 days, you will learn about the new requirements in the Medical Device Regulation (MDR), including those related to quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and postmarket surveillance. You will also learn how to plan an efficient transition. Describe the objectives and structure of the MDR. Identify the key new requirements in the MDR. Explain the impact of the new MDR requirements on economic operators, including manufacturers. Identify the necessary steps to prepare an organization to transition to the MDR. Learn how to conduct a gap assessment as part of the transition to the new requirements. Medical device professionals in areas of quality and regulatory affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market or plan to market devices in the EU. The objectives of the MDR Quality management system requirements in the MDR Device classification and conformity assessment route changes in the MDR Technical documentation requirements in the MDR Clinical evaluation process requirements in the MDR UDI and traceability requirements in the MDR Postmarket surveillance and reporting requirements in the MDR Life-cycle review of products linked to risk management and clinical evidence Auditing impact of the MDR $2495 Course Code: EMF 1.5 CEUs 2 Days JANUARY 8 9 Orlando, FL APRIL 9 10 Chicago, IL JANUARY Indianapolis, IN APRIL San Diego, CA FEBRUARY 5 6 Edison, NJ MAY Orlando, FL FEBRUARY 5 6 Dublin, Ireland MAY Edison, NJ FEBRUARY Minneapolis, MN JUNE 4 5 Minneapolis, MN FEBRUARY San José, Costa Rica JUNE Boston, MA MARCH 5 6 San Francisco Area, CA JULY 9 10 Chicago, IL MARCH Frankfurt, Germany JULY San Diego, CA MARCH Boston, MA JULY San José, Costa Rica PLANNING YOUR EU MDR TRANSITION Transitioning to the new EU Medical Device Regulation (MDR) won t be easy, but companies that start their transitions early and follow a solid, well-developed transition plan will find themselves with a competitive advantage. What should you be considering now? Is your device covered by the MDR or IVDR? Will the class of your device change? Will you need to use a different conformity assessment route? Do you have enough clinical evidence? What do you need to add to your technical documentation? Are you prepared to meet new postmarket requirements? Are there opportunities to optimize existing support processes that can help offset costs incurred from making the transition? Do you have the in-house resources available to make the transition within the required time frame? Given the scope of the changes, it is unlikely that any one organization has all the necessary skills and resources in-house to effectively complete their transition. Oriel STAT A MATRIX s experienced consultants can help. NEXT STEPS Prepare your team. Understand the MDR s updated requirements with our new course Transition to the New EU Medical Device Regulation (MDR). Assess your product portfolio. Let us help you evaluate how the changes to classification criteria will affect your products. Conduct a comprehensive regulatory assessment. To learn more, call or info@orielstat.com. For additional dates and locations or to register

4 PGE MEDICAL HEADDEVICE RA/QA NEW! Transition to the Medical Device Single Audit Program (MDSAP) The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to consolidate compliance audits from five separate markets or Regulatory Authorities (RAs) with a single audit. Currently, Australia, Brazil, Canada, Japan, and the United States are participating in the program with Health Canada requiring MDSAP certification by January Our 2-day course provides a solid understanding of the MDSAP, what to expect during an MDSAP audit, and the key regulatory requirements for MDSAPparticipating countries. Through interactive workshops and exercises, participants apply the MDSAP process-based audit approach including the scoring system that Auditing Organizations (AOs) will use during certification audits. Participants in this class gain additional insight from case studies that share best practices and include practical examples gathered from our customers who have successfully passed their MDSAP certification audits. Present an overview of the MDSAP. Identify MDSAP roles and responsibilities. Assess the benefits and challenges of participating in the MDSAP. Describe the MDSAP audit model and how it is used, including objectives, the evidence sought, audit tasks, and process linkages. Explain how MDSAP auditors use the nonconformity grading matrix. Identify the necessary MDSAP preparation steps, including activities related to a gap assessment, the internal audit team, and planning for MDSAP participation. Anyone engaged in their organization s quality management system, regulatory compliance, QA/QC, and internal auditing. Health Canada will require MDSAP certification by January 2019 if you sell in Canada, make sure you plan ahead. MDSAP objectives MDSAP roles and responsibilities The MDSAP audit model and audit process The nonconformity grading matrix Preparing for the MDSAP HIGHLIGHTED HANDOUTS MDSAP Audit Checklist MDSAP Organizational Readiness Tool MDSAP Audit Tasks by Additional Country- Specific Requirements: An Analysis MDSAP Audit Tasks by Process: An Analysis The MDSAP Nonconformity Grading Tool Quality Plan Template: Prepare for MDSAP Participation Prepare for MDSAP Success Does having one audit that counts for five different regulatory authorities sound interesting? If so, then you re not alone. For many device manufacturers, the MDSAP s potential to open up new markets and streamline audit processes is a major draw. For others, Canada s requirement for MDSAP certification is driving their decision to participate in the program. Whatever your motivation, Oriel STAT A MATRIX s MDSAP Auditor Consultants will ensure you are ready for your MDSAP Certification Audit. Using the same Process-Based MDSAP Audit Model and the MDSAP nonconformity grading matrix as the Auditing Organizations (AO) will use, we can: Conduct an MDSAP Baseline or Preassessment Audit. Coach your team on the MDSAP Process-Based Audit Approach. Facilitate remediation of any issues found during the audit. Develop and review MDSAP audit checklists. Align your internal audits to the MDSAP process. Assess if your products are registered properly in the participating countries and meet the MDSAP reporting requirements. Provide additional support you may require. Completing these activities in addition to taking our MDSAP transition training class will ensure that your organization is equipped with the skills and knowledge you need for a successful MDSAP certification audit. To learn more, call or info@orielstat.com. $2495 Course Code: SAF 1.5 CEUs 2 Days JANUARY San Diego, CA MARCH Boston, MA JUNE 6 7 Indianapolis, IN JANUARY Chicago, IL MARCH Minneapolis, MN JUNE Minneapolis, MN JANUARY Edison, NJ MARCH Raleigh, NC JUNE San Diego, CA JAN 31 FEB 1 Irvine, CA APRIL San Diego, CA JUNE Chicago, IL FEBRUARY 7 8 Indianapolis, IN APRIL Chicago, IL JULY Austin, TX FEBRUARY Austin, TX APRIL Edison, NJ JULY Irvine, CA FEBRUARY San José, Costa Rica MAY 2 3 San Francisco Area, CA JULY San José, Costa Rica FEB 28 MAR 1 San Francisco Area, CA MAY 9 10 Orlando, FL AUGUST 1 2 Edison, NJ MARCH 7 8 Orlando, FL MAY Boston, MA AUGUST 8 9 Indianapolis, IN All of our courses can be delivered on-site

5 MEDICAL DEVICE RA/QA MARCH 2019 You have until March 2019 to update your current ISO certification to ISO 13485:2016. Make sure you re prepared! Internal Auditor Training for ISO CERTIFIED QMS INTERNAL AUDITOR TRAINING COURSE UPDATED! Transition to ISO 13485:2016 Updates include discussions on ISO 13485:2016 s relationship with MDSAP (page 4) and the EU s new Medical Device Regulation (MDR) (page 3). Major changes in ISO 13485:2016 include an increased focus on risk management throughout the product life cycle, the supply chain, and device usability and postmarket surveillance requirements. In this course, you will thoroughly review the revised standard, assess its impact on your quality management system, and gain actionable knowledge including best practices focused on auditing to the revised standard so that you ll be ready for your ISO 13485:2016 upgrade audit. Describe the background, drivers, and transition period for the ISO 13485:2016 standard. Describe the relationship of ISO to the European Union (EU) directives/regulations, US 21 CFR 820, and MDSAP. Identify best practices in process management, risk management, risk-based approaches, and usability. Describe how to integrate risk-based thinking and use a risk-based approach for QMS processes and auditing. Explain the changes, intent, and guidance for ISO 13485:2016 (Introduction, Scope, Definitions, Clauses 4-8) and practice assessing gaps and audit readiness. Describe the purpose, entities, benefits, and challenges associated with the MDSAP. Describe MDSAP processes, audit tasks, and the nonconformity grading scale. Recognize the challenges associated with medical device transitions and the available resources. Relationship between ISO 13485:2016 and EU device directives/regulations, FDA s QSR, and MDSAP Difference between risk-based control of processes and risk management for product safety Changes and intent in the new standard, with opportunities for gap assessment and audit practice Anyone engaged in the implementation or auditing of their organization s quality management system. $1995 Course Code: TNF 1.5 CEUs 2 Days JANUARY 8 9 San Diego, CA MARCH Raleigh, NC JANUARY Chicago, IL APRIL 9 10 San Diego, CA JANUARY Austin, TX APRIL Chicago, IL JANUARY Irvine, CA APRIL Edison, NJ FEBRUARY 5 6 Indianapolis, IN APR 30 MAY 1 San Francisco Area, CA FEBRUARY Edison, NJ MAY 7 8 Orlando, FL FEBRUARY San José, Costa Rica MAY Boston, MA FEBRUARY San Francisco Area, CA JUNE 4 5 Indianapolis, IN MARCH 5 6 Orlando, FL JUNE Minneapolis, MN MARCH Boston, MA JUNE San Diego, CA MARCH Minneapolis, MN JUNE Chicago, IL Outstanding instructor. This was the best class I ve taken in years. The instructor s mix of analogies, humor, and overall knowledge was superb and created an optimal learning environment. Quality Manager Learn how to plan and perform internal audits of quality management systems against the requirements of ISO 13485:2016. Based on our Exemplar Global certified lead auditor course, this class includes workshops tailored to the changing medical device industry and discussions of auditing techniques and best practices with an increased focus on internal audits. Exercises and workshops feature audit criteria from ISO 13485:2016. Understand the core concepts of an effective quality system such as process and risk-based approaches. Learn about the ISO 9000 standard series and how ISO 9001:2015, FDA s Quality System Regulation, and ISO 13485:2016 requirements are related. Explain how to plan and execute an internal audit, as well as conduct follow-up activities using concepts detailed in ISO The quality management system Analysis and interpretation of ISO Process and risk-based auditing techniques The quality audit cycle Describe what third-party assessors look for when they audit your organization. Practice collecting audit evidence and documenting observations including using techniques for effective questioning and listening during course workshops. Describe how to verify the effectiveness and adequacy of corrective action, close out an audit, and conduct follow-up surveillance audits. Preaudit activities On-site audit activities Report writing and nonconformity reports Corrective action and audit follow-up There are two quizzes during the training and a one-hour, open-book final exam on the last day. For training certification, attendees must meet class participation requirements, pass the quizzes and exam, and attend the full session. This is a perfect fit if you will be conducting, managing, or participating in internal (first-party) audits or helping to develop an ISO compliant quality system. NOTES: This training course is an Exemplar Global certified course. To attain registration as a QMS Auditor/Senior Auditor/Lead Auditor, you must pass the written examination, earn a passing grade in the course assessments, and meet prescribed professional requirements. See page 15 for full details. Exemplar Global requires that all attendees study the current published version of ISO before attending this class. $1995 Course Code: IAF 2.5 CEUs 3 Days JANUARY Edison, NJ MAY 8 10 Minneapolis, MN FEBRUARY Chicago, IL MAY San Francisco Area, CA MARCH San Diego, CA JUNE Edison, NJ APRIL 3 5 Boston, MA JULY Chicago, IL APRIL Orlando, FL AUGUST 7 9 San Diego, CA All of our courses can be delivered on-site 5

6 MEDICAL DEVICE RA/QA Lead Auditor Training for ISO CERTIFIED QMS LEAD AUDITOR TRAINING COURSE Over 130,000 auditors trained in ISO 13485, ISO 9001, and related standards since 1990! Gain a thorough understanding of how to conduct effective audits of quality management systems for medical devices through expert instruction, engaging class discussion, and interactive workshops using ISO 13485:2016 as the primary audit criteria. Workshops reinforce key topics, including development of audit tools and checklists, opening and closing meetings, listening and questioning techniques, interpretation of auditor evidence, nonconformance reports, and audit documentation. Our approach teaches the audit discipline in accordance with ISO while providing a sector-focused learning experience for those engaged in the medical device industry. Over 5 rigorous days, go through every phase of an audit from planning to conducting to following up so you will be able to lead your own audits efficiently and effectively against the ISO standard. Quality System Foundations Understand the core concepts of an effective quality system, such as process and risk-based approaches. The Requirements Learn about the ISO 9000 standard series and the relationships among ISO 9001:2015, FDA s Quality System Regulation, and ISO 13485:2016 requirements. Audit Process Understand the QMS registration process and the various types of audits along with auditor responsibilities in each. Preaudit Activities Learn how to plan all aspects of an audit. Conducting the Audit Learn how to collect objective evidence. Postaudit and Follow-Up Activities Learn how to present audit results and follow up. Interpretation and use of ISO 13485:2016 The audit cycle and ISO Audit planning activities Process and risk-based auditing techniques Interviewing and listening techniques Evidence collection techniques and sampling Nonconformity reporting Audit follow-up and corrective action Although this course was originally designed to train third-party auditors, most of the participants lead their company s quality system implementation and/or audit programs. Ideal for anybody involved in a supplier quality assurance program. COURSE REQUIREMENTS Evening study recommended. A 2-hour final exam is required. NOTES: This training course is an Exemplar Global certified course. To attain registration as a QMS Auditor/Senior Auditor/ Lead Auditor, you must pass the written final examination, earn a passing grade in the course assessments, and meet prescribed professional requirements. For full details of Exemplar Global certification, please see page 15. Exemplar Global requires that all attendees study the current published version of ISO before attending this class. Audit Report Audit satisfactory Observations made nconformances MOVE BEYOND CONFORMANCE with an Oriel STAT A MATRIX AUDIT An Oriel STAT A MATRIX quality management system (QMS) audit goes beyond surface findings to examine process interactions and efficiency. Whether you need to supplement your internal team for a single audit or require support for a global supplier audit program, choose Oriel STAT A MATRIX to provide an independent, unbiased, and objective view of your quality system and processes. Partner with Oriel STAT A MATRIX for: Internal audits Baseline assessments FDA and MDSAP mock audits Preassessments prior to a Certification Body audit Practice audits with newly trained auditors to ensure they are correctly applying the tools they learned Because we are consultants, not a Certification or Regulatory Body, we can also provide suggestions on how to improve your processes and how your suppliers can improve their operations to help them better meet your quality requirements. To learn more, call or info@orielstat.com. $2695 Course Code: LAF 4.4 CEUs 5 Days JANUARY 8 12 Boston, MA MARCH 5 9 San Francisco Area, CA MAY 7 11 Orlando, FL JANUARY San Diego, CA MARCH Indianapolis, IN MAY San Francisco Area, CA JANUARY Minneapolis, MN MARCH Edison, NJ JUNE 4 8 Edison, NJ JAN 29 FEB 2 Raleigh, NC MARCH Irvine, CA JUNE Indianapolis, IN FEBRUARY 5 9 Austin, TX APRIL 9 13 Boston, MA JUNE Boston, MA FEBRUARY San José, Costa Rica APRIL San Diego, CA JUNE San Diego, CA FEBRUARY Chicago, IL APRIL Minneapolis, MN JULY 9 13 Minneapolis, MN FEB 26 MAR 2 Orlando, FL APR 30 MAY 4 Chicago, IL JULY San José, Costa Rica All of our courses can be delivered on-site

7 MEDICAL DEVICE RA/QA UPDATED! Quality Systems for Medical Devices: FDA s QSR and ISO 13485:2016 UPDATED! Developing and Maintaining a GMP/ISO-Compliant Document Management System The must-take foundation course for all medical device RA/QA professionals! Updated content includes an introduction to the Medical Device Single Audit Program (MDSAP) (page 4) and FDA s Case for Quality (page 12). Designed for those who are new to the medical device field as well as experienced practitioners looking to refresh their knowledge, this course provides a comprehensive introduction to the requirements of FDA s Quality System Regulation (QSR) and ISO 13485:2016. Through engaging classroom discussion, workshops, and activities, you will follow a product s life life cycle to explore how different elements of ISO and FDA s QSR should be implemented at each life-cycle phase. You will address the major QMS subsystems and learn how to prepare for a Notified Body or FDA inspection. You ll come to understand how QSR and ISO 13485:2016 align with one another, how they can be harmonized to maximize efficiency, and where there are opportunities to go beyond the minimum requirements to optimize performance. At the end of this class you ll have a a solid foundation on which to build a successful career in medical device RA/QA. Describe the objectives of ISO 13485:2016 and FDA s QSR. Identify the requirements of ISO 13485:2016 and FDA s QSR. Apply the requirements of ISO 13485:2016 and FDA s QSR. Identify the common elements found in global QMS requirements. Describe how to plan and prepare for FDA, Notified Body, and Medical Device Single Audit Program (MDSAP) inspections/audits. Identify opportunities beyond compliance, including FDA s Case for Quality. Plan and prepare for FDA and Notified Body inspections/audits. FDA QSR background and subpart review compared against ISO standard clauses Major subsystems: management controls, design controls, production and process controls, and CAPA Application of risk-based approach Going beyond the minimum requirements, including FDA s Case for Quality This course is appropriate for anyone who needs to understand how to meet the requirements of a global medical device quality system. $2695 Course Code: GRF 2.5 CEUs 3 Days JANUARY Edison, NJ APRIL Indianapolis, IN JAN 30 FEB 1 Orlando, FL APRIL Edison, NJ FEBRUARY 6 8 San Diego, CA MAY 1 3 Orlando, FL FEBRUARY Chicago, IL MAY San Diego, CA FEBRUARY Austin, TX JUNE 5 7 Chicago, IL FEB 27 MAR 1 San Francisco Area, CA JUNE Raleigh, NC FEB 28 MAR 2 San José, Costa Rica JULY San Francisco Area, CA MARCH Irvine, CA JUL 31 AUG 2 Minneapolis, MN MARCH Minneapolis, MN AUGUST 1 3 San José, Costa Rica APRIL 3 5 Boston, MA AUGUST Boston, MA Excellent explanation and interpretation of requirements in understandable language. Quality Manager Documentation Management Strategies for the 21st Century Documentation practices are evolving, so to avoid FDA or Notified Body findings you must stay ahead of the curve in this critical area. Over 2 days you ll learn best practices and strategies to plan and improve a documentation control system and prepare for audits under the new EU regulations, ISO 13485:2016, and FDA s QSIT. Risk-based change management strategies critical for FDA compliance and business efficiency are a key focus in this course. Document management is one the fundamental cornerstones of an effective quality management system. Don t be left short! At the end of this workshop, participants will be able to: Describe the requirements of regulations and standards (FDA, EU device regulation, and ISO 13485) as they relate to document control. Plan and structure a document management system that meets new requirements for EU Technical Documentation. Identify software used in QMS documentation and regulation of electronic records and electronic signatures in 21 CFR Part 11. Apply process mapping to documentation practices to articulate process linkages for MDSAP. Evaluate best practices in technical writing and good documentation practices. Review the basics in documentation, including mandatory and recommended elements for policies, procedures, and instructions. Develop a robust change control system linked to your design and risk control activities. Describe best practices in preparing for successful outcomes from FDA, Notified Body, and MDSAP audits. Documentation requirements (global regulations and standards) Technical writing, process mapping, and error proofing Electronic records Change control requirements Recommended for staff members involved in preparing plans, procedures, and instructions as part of a document management system. JANUARY MARCH MAY AUGUST 1 2 OCTOBER 3 4 DECEMBER 5 6 $1995 Course Code: DOF 1.5 CEUs 2 Days Minneapolis, MN Edison, NJ Orlando, FL Chicago, IL Boston, MA San Diego, CA For additional dates and locations or to register

8 MEDICAL DEVICE RA/QA Implementing Design Control Requirements and Best Practices It was fantastic to use real-life examples in class! They greatly helped me understand the concepts being taught and apply them when I got back to work. Quality Engineer Design controls are an integrated set of management practices that are applied to control the process of design and development. Processes are characterized by activities that transform inputs into outputs. Focusing on the process first allows for a more robust assessment of the inputs and outputs. Design controls per FDA and ISO 13485:2016 can then be mapped to the process that works for the organization and the product being developed. Is your product development process linear or is it more iterative? Both process models require certain design control elements. In this class, you ll learn strategies and best practices for managing these processes, thus ensuring that your organization s devices meet user needs, intended uses, and specified requirements. Understand the reason for design control and the current problems facing medical device companies today. Review and compare design control in the QSR and ISO 13485:2016. Understand the process model approach to design control. Understand the phases of the product life cycle and their relation to design control. Identify the fundamentals and key elements of the design control process. Develop the proper interface of design control with risk management and CAPA processes. Guide their organization in establishing design controls in its processes/procedures. Recognize and apply the proper use of post-production information in design control. Learn expectations of the FDA and its QSIT approach to inspection in relation to design control. FDA, ISO, and design control Principles of the process model Product life cycle and design control Design control, risk management, and CAPA Overview of the design control process Building a compliant design history file (DHF) QSIT with design control Anyone managing, developing, or engaging in the design of medical devices, including direct engineering functions, QA/QC, production management, and regulatory, as well as anyone else who has a role in building a robust regulatory-compliant environment. $2895 Course Code: DBF 2.5 CEUs 3 Days JANUARY Chicago, IL APRIL 3 5 Boston, MA FEBRUARY Edison, NJ MAY 1 3 Minneapolis, MN MARCH 6 8 Orlando, FL JUNE 5 7 San Diego, CA MARCH Indianapolis, IN JULY Chicago, IL Risk Management for Medical Devices: ISO Effective risk management spans the product life cycle, from concept of design to postmarket surveillance and eventual obsolescence. Employing risk management from the start saves time and money, and reduces exposure after commercialization. Our risk management course covers ISO 14971, how to manage the differences between ISO 14971:2007 and EN ISO 14971:2012, and the application of risk management practices throughout a product s full life cycle. Updated content examines ISO 13485:2016 s increased focus on risk management, as well as how US, Canadian, and global regulators view risk management and what they expect to find at your organization. Using interactive hands-on workshops and group discussions, course participants develop the knowledge and skills necessary to understand the risk management process and each of the risk management steps. Understand hazards, harms, and risks. Learn how to create a risk management plan, a risk management file, and a risk management report. Be able to perform the risk management process according to ISO Understand and manage the difference between ISO 14971:2007 and EN ISO 14971:2012. Become familiar with common risk management tools, such as design/ process FMEA and FTA. Be able to conduct the post-production risk assessment. Fundamental risk management concepts and definitions Global regulatory compliance requirements for risk management, including US, EU, and Canada How the FDA and other global regulators interpret risk management The evolution of ISO 14971, its purpose, and a comprehensive review of the key clauses Integrating risk management into your product development life cycle and quality management system Elements of an effective risk management plan Requirements for each step of the risk management process, including risk management plan, risk analysis, risk evaluation, risk control, risk management file, and post-production analyses The impact of postmarket activities on risk, including postmarket design, CAPA activities, and governmental postmarket surveillance The major tools and methods of risk analysis and hazard analysis: estimating, evaluating, controlling, and reducing risks This course is recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, and regulatory affairs professionals; and other crossfunctional team members in a medical device environment. $2895 Course Code: RMF 2.5 CEUs 3 Days JANUARY 9 11 Orlando, FL APRIL San Francisco Area, CA JANUARY Minneapolis, MN MAY 1 3 Orlando, FL FEBRUARY 6 8 San Diego, CA MAY Minneapolis, MN FEBRUARY Boston, MA JUNE 5 7 Chicago, IL MARCH 6 8 Chicago, IL JUNE Boston, MA MARCH Indianapolis, IN JULY San Diego, CA APRIL 3 5 Edison, NJ JUL 31 AUG 2 Edison, NJ All of our courses can be delivered on-site

9 MEDICAL DEVICE RA/QA Complaint Handling, UPDATED! Vigilance Reporting, and Recall Management: From Compliance to Best Practices Updates include the new EU Medical Device Regulation s (page 3) postmarket surveillance requirements, and vigilance reporting requirements from China, the EU, and all five MDSAP countries (page 4). Postmarket monitoring requirements and greater attention to postmarket regulation are on the rise across the globe. From the EU s new Medical Device Regulation to ISO 13485:2016 s changes in feedback and reporting as well as continued scrutiny by US FDA this is not an area you can afford to ignore. Over 3 engaging days you ll cover a range of topics, including conducting postmarket surveillance, addressing field corrections and recalls, and best practices for managing audits and inspections from global regulators (including MDSAP auditors). Emphasis is placed on efficient processes and a proactive approach for addressing this critical area. At the end of this course, participants will be able to: Describe key regulatory Identify reporting requirements requirements for handling in the EU, China, and MDSAP complaints, vigilance, and field countries. actions. Apply a risk-based approach to Identify best practices for needed corrections and removals. structuring the complainthandling process and the requirements, including those in Identify postmarket surveillance Complaint-Handling Unit. the EU Medical Device Regulation. Perform complaint intake, triage, Explain how to prepare for audits investigation, and closure. of the complaint-handling system, Describe the role of risk management including FDA, Notified Body, and and CAPA in effective complaint MDSAP. handling. Complaint handling, event reporting, corrections, and removals Complaint intake, triage, investigation, vigilance decisionmaking, closure documentation, and trending Vigilance reporting in the EU, China, and MDSAP countries Risk management using ISO and linkages with corrections, removals, and recalls Postmarket surveillance requirements: ISO 13485:2016, US FDA, EU Medical Device Regulation, and Canada Audit preparation Anyone who needs to understand and apply the regulatory requirements for complaint handling and event reporting. UPDATED! Identify software development life cycle (SDLC) phases, processes, and deliverables. Map these phases, processes, and deliverables to US and global regulatory requirements/standards. Describe how to apply risk management principles and perform risk-based software tool validation. The SDLC, including examples of commonly used SDLCs Verification and validation Key regulations/standards/ guidance, including IEC 62304, AAMI TIR36, ISO/TR , and AAMI TIR45 Risk management processes and risk-based validation Design control and software validation guidance Testing level strategies (unit, integration, system, user) Software Verification and Validation Requirements Recently updated content includes a greater focus on IEC (specifies life-cycle requirements for the development of medical software and software within medical devices), risk management for software, and the Agile approach for software development. US FDA and international regulatory standards relating to software continue to evolve and become more stringent. This makes the process of validation and verification (V&V) even more important not only to comply with regulations, but also to ensure patient safety. In this class, you will learn how to apply US and international regulatory requirements and standards for the design and development of medical device software, including product software that is part of a medical device, product software that comprises the medical device, and quality management system (QMS) software that is used in any regulated process in the design, manufacture, distribution, and/or support of a device. Identify requirements for validating nonproduct software (QMS software). Describe how Agile software development aligns with regulatory expectations for software validation. Assess real-world lessons learned and identify the benefits of an SDLC, including time to market. Methods development and documentation requirements Test protocol content Configuration and change management Documentation requirements for premarket submissions Process, procedures, and outputs for typical phases Defects and issues management Design and quality planning, including traceability and reviews Agile software development Recommended for computer system/software users, mid-level managers, software developers/engineers/testers, product managers, regulatory personnel, and quality assurance professionals in FDA-regulated fields. $2895 Course Code: CHF 2.5 CEUs 3 Days JANUARY San Francisco Area, CA APRIL Orlando, FL JAN 30 FEB 1 Edison, NJ MAY 8 10 Edison, NJ FEBRUARY Indianapolis, IN MAY Chicago, IL FEB 27 MAR 1 San Diego, CA MAY San Diego, CA MARCH Boston, MA JUNE Boston, MA MARCH Chicago, IL JULY Minneapolis, MN APRIL Minneapolis, MN JULY Orlando, FL $2495 Course Code: SVF 1.5 CEUs 2 Days JANUARY Chicago, IL MARCH Edison, NJ MAY Orlando, FL JULY 9 10 San Diego, CA SEPTEMBER Boston, MA NOVEMBER 1 2 Minneapolis, MN For additional dates and locations or to register

10 MEDICAL DEVICE RA/QA Optimizing CAPA Programs for the Medical Device Industry Root Cause Analysis for Life Science Investigations The course s emphasis on participation helped me baseline my program s maturity, which revealed multiple improvement opportunities. I highly recommend this class. Quality Manager Repeat CAPAs occur when problems we thought had been resolved crop up again. When such problems persist, product and regulatory issues may arise. Your organization can stop this cycle by refining your CAPA program to address CAPAs effectively and efficiently. In this course, you will learn how to optimize your CAPA program by addressing common issues at the program level (e.g., improving timeliness, connecting CAPAs, and leveraging trending), the action level (e.g., addressing human error, applying interim actions, and verifying the effectiveness of CAPA actions), and the problem level (e.g., identifying the root cause, correcting it, and fixing the symptoms). An optimized CAPA program supports continuous product and business improvements, satisfies regulatory requirements, and prevents those dreaded repeat CAPAs. Understand what is included in an effective CAPA program and where the data comes from. Learn how to integrate your CAPA program to further enhance your quality system. Understand FDA s and other regulatory officials expectations for what CAPA is and the steps required to get you there. Learn not only what is expected from your organization, but also how you can use it to impact the bottom line. What is CAPA and when is it required? CAPA program pitfalls and best practices Risk-based decision making for corrections and removals Understand why regulatory agencies added the preventive action clause to the requirements. Understand how to differentiate and document known problems versus identifying those problems that require further investigation and CAPA. Develop a risk-based approach to the CAPA process to determine the depth of investigation, CAPA cycle time, and any immediate corrections your organization needs to take. Recommended for top management, management representatives, and staff in: Compliance/regulatory affairs QA/QC Manufacturing operations CAPA management Elements of effective CAPA: roles, inputs, and metrics CAPA methodology: from problem definition to effectiveness checks Basic root cause analysis CAPA communication Information systems/technology Document management Distribution Research and development $1995 Course Code: CAF 1.5 CEUs 2 Days JANUARY 8 9 Boston, MA JUNE 5 6 San Francisco Area, CA JANUARY Orlando, FL JUNE Indianapolis, IN FEBRUARY San Diego, CA JUL 31 AUG 1 Boston, MA MARCH Minneapolis, MN AUGUST Orlando, FL APRIL Edison, NJ SEPTEMBER San Diego, CA MAY 7 8 Chicago, IL OCTOBER Minneapolis, MN Bring this training on-site. We can tailor the content to focus on the tools you use most and include your company s unique examples! Root cause analysis (RCA) is the essential investigation method used by life science professionals to understand failures throughout a product s life cycle. Using workshops, case studies, and simulations, you ll walk through the entire root cause analysis process, from accurately identifying and defining a problem to designing an effective intervention. Updated course content addresses the importance of creating a problemclosing culture that allows organizations to both solve and recover from problems more quickly, applying project management in RCA, and documenting the root cause investigations. Understand the benefits of creating a problem-solving culture. Gain insight into strategies for selecting problems based on risk and impact. Create an effective problem statement. Understand and apply the tools for successful RCA: Problem definition and focus (ONE, TAGS, is/is not) Investigation (brainstorm, affinity diagram, 5 Whys, tree diagrams, cause and effect, distinctions/changes) Data analysis (types of data, charts, plots) Solution selection (Pugh, decision matrix) Verifying effectiveness (hypothesis testing) Project management (Gantt, PERT, charter) People management (team formation, commitment tool) Monitoring and sustaining gains (self-audit, process management) Documenting investigations (A3, writing for the audience) Identify strategies for managing people, projects, and processes. Understand the various perspectives on root cause analysis Create teams to address specific problems Define the scope of a problem Use data collection and analysis strategies to: Focus or localize the problem Identify and verify root causes Measure the results of implementing a solution Conduct root cause analyses Develop plans to implement solutions Document problem investigations This course is a good fit for anyone from the medical device, biotech, and pharmaceutical industries participating in root cause analysis investigations. $2895 Course Code: RCF 2.5 CEUs 3 Days Boston, MA Orlando, FL Edison, NJ Chicago, IL San Diego, CA Minneapolis, MN JANUARY JAN 31 FEB 2 APRIL MAY 9 11 SEPTEMBER OCTOBER All of our courses can be delivered on-site

11 MEDICAL DEVICE RA/QA Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark] Is the 510(k) appropriate for my device? When am I allowed to affix a CE Mark? Supplier Quality Management: Designing a Successful Program Warning letter citations related to purchasing controls have more than doubled in the past 5 years. How can you get your product to market in the US or EU? In this course, learn about the available options and how to use strategic thinking to make a sound decision. You ll explore questions such as: When is a product regulated in the US/EU? What should I consider when I assess paths to market? When is it advantageous to talk to FDA before a formal submission? What impacts the review time and what can I control? When would it make more sense to enter the EU before the US? Interactive exercises and workshops reinforce course concepts and include classifying devices, evaluating substantial equivalence arguments, and making recommendations. Identify the US pathways to market as well as their advantages and disadvantages. Apply a strategy to choose an appropriate regulatory pathway. Describe how to establish substantial equivalence for a 510(k) premarket notification. Identify the necessary sections of a 510(k) premarket notification. Explain the role of the CE Mark in the EU. Describe EU device classification and pathways to market. Identify the necessary sections of a technical file. Describe submission best practices. US device classification US regulatory submissions strategy US pathways to market, including: 510(k) premarket notification De novo PMA premarket approval FEBRUARY 6 8 MARCH MAY JUNE EU CE Marking EU Directives (MDD, AIMD, IVDD) EU device classification EU conformity assessment routes Technical files and design dossiers Medical device quality and regulatory affairs professionals with a need to understand how to select an appropriate regulatory submission/clearance pathway for a medical device in the US and/or the EU. Get your devices approved faster! Our team can help you successfully navigate the 510(k), PMA, or CE Marking processes so that your devices are approved more quickly, more efficiently, and with greater chances of success. Call or info@orielstat.com to learn more. $2895 Course Code: WSF 2.5 CEUs 3 Days Boston, MA Chicago, IL San Diego, CA Orlando, FL FDA and EU inspections are turning up countless supplier control violations. Poorly designed and executed supplier audits can cost your company millions and put you at risk of 483s and warning letters. With dozens, hundreds, or even thousands of suppliers to manage, you need a proven risk-based process that meets FDA and ISO 13485:2016 enhanced requirements, as well as ensures high-quality products and protects patient safety. This course will provide your organization with the knowledge and tools to design a comprehensive cross-functional supplier quality program. It will also help your company proactively address the development and strengthening of processes and procedures for all aspects of supplier quality management. Requirements for establishing an effective and efficient system will be detailed, from creating product development specifications through maintaining an approved supplier listing. Understand the regulatory background for supplier quality. Develop business solutions for building a supplier quality program. Translate product development and manufacturing needs into supplier specifications. Establish a process for assessing and qualifying suppliers. Develop and maintain an approved supplier listing. Apply auditing skills when working with suppliers. Understand the life cycle of vendor management. Communicate supplier quality program status to the management team. Regulatory requirements for medical device and pharmaceutical supplier quality programs Business needs for and impact of a comprehensive supplier quality program How to assess potential vendors to meet organizational requirements Generation and maintenance of approved supplier lists Risk-based approach for vendor qualification and management Conducting vendor audits Identification and resolution of vendor issues Designed for personnel involved in sourcing, securing, and maintaining suppliers and services who ensure excellent product quality and organizational reputation. JANUARY FEBRUARY MARCH MARCH APRIL MAY 1 3 MAY JUNE JULY $2895 Course Code: SQF 2.5 CEUs 3 Days Indianapolis, IN Boston, MA Chicago, IL Edison, NJ San Diego, CA Orlando, FL Minneapolis, MN San Francisco Area, CA Boston, MA For additional dates and locations or to register

12 MEDICAL DEVICE RA/QA Process Validation Principles and Protocols More than IQ, OQ, and PQ a solid validation system includes master validation planning, effective protocol writing, and change communication. NEW! Performance-Based Auditing: A Tool for FDA s Case for Quality Calling all experienced auditors! How confident are you that your processes have the controls in place to produce safe and effective products? FDA s 21 CFR 820 and ISO 13485:2016 require process validation, but they don t offer much guidance. During this class, participants gain the knowledge and skills needed to comply with the process validation requirements of FDA s Quality System Regulation and ISO 13485:2016, as well as information on how to implement an effective validation program. You ll take a simple process through the entire validation cycle writing protocols, determining key operating parameters, and identifying data analysis strategies. You will learn how to interpret the regulations, standards, and guidance documents; correctly apply the principles of risk management; create qualification protocols (IQ, OQ, PQ); and identify statistical methods and tools when implementing and maintaining process validation activities. Through interactive discussion and workshops, you ll evaluate real-world process validation examples and warning letters, and learn best practices for the practical application of process validation in medical device manufacturing. Identify and describe key concepts needed to successfully conduct process validations. Explain the purpose of process validation and when it is needed. Identify and manage sources of variation in measurement systems. Describe the validation life cycle. Define the purpose and contents of a validation master plan (VMP). Explain the intent of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Describe the protocol and requirements for IQ, OQ, and PQ. Process validation requirements The role of the following in process validation: quality management systems, metrology and measurements systems, risk management, and quality tools and analysis FDA and ISO process validation requirements The validation master plan Installation qualification (IQ) Operational qualification (OQ) Performance qualification (PQ) Recommended for quality, regulatory, engineering, manufacturing, and other technical professionals who plan, execute, report, maintain, review, or manage process validation activities, and who have basic knowledge of statistics or statistical tools. This course is tailored to medical device companies but will also provide value to students from pharmaceutical companies. $2895 Course Code: PVF 2.5 CEUs 3 Days JANUARY Indianapolis, IN APRIL Boston, MA JAN 30 FEB 1 Edison, NJ APRIL Chicago, IL FEBRUARY San Francisco Area, CA MAY 8 10 Edison, NJ FEB 27 MAR 1 Orlando, FL MAY Orlando, FL MARCH Minneapolis, MN JUNE Minneapolis, MN MARCH San Diego, CA JUNE San Diego, CA FDA s Case for Quality elevates the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes. How can your organization become quality mature? Fusing decades of auditing expertise and performance improvement consulting experience, Oriel STAT A MATRIX has developed Performance-Based Auditing for Medical Devices, a methodology designed to move your audits beyond compliance. In this class, you will learn how to analyze process performance data and document the: Effectiveness of the management system in achieving business results. Efficiency of the management system processes toward achieving business results with the least amount of resources. Armed with this information, you will have the skills and knowledge to analyze data and identify opportunities to improve process performance, product quality, and customer satisfaction. This information will allow you to speak the language of the boardroom: dollars and cents. As well, it is key to FDA s Case for Quality and its focus on the use of critical-to-quality design and production practices that support higher-quality results. Recognize the difference between compliance-based auditing and performance-based auditing. Learn how a performance-based audit program connects process metrics to key indicators of business performance. Learn how to apply: Performance-based methodologies for preparing and conducting audits. Statistical tools that assess process performance and product characteristics, including the use of Minitab statistical software. A process performance scoring system (and connecting it with nonconformities). The fundamentals of performancebased auditing: More robust methodologies for preparing and conducting audits Auditor competence Enhanced audit criteria that consider efficiency and effectiveness Applied statistics for auditing Planning, conducting, and reporting a performance-based audit Linkages between the process approach to auditing and key performance indicators (KPIs) Measuring audit program effectiveness Designed for experienced management system auditors who have successfully completed an auditing course and performed actual audits, as well as audit program managers and QMS management representatives. $2995 Course Code: PBF 4 CEUs 5 Days FEBRUARY Orlando, FL JULY Edison, NJ APRIL 9 13 Minneapolis, MN SEPTEMBER Chicago, IL MAY San Diego, CA NOVEMBER 5 9 Boston, MA All of our courses can be delivered on-site

13 130,000 and COUNTING! Oriel STAT A MATRIX has been training auditors longer than any other training organization in the world. Lead Auditor Training for ISO 9001 CERTIFIED QMS LEAD AUDITOR TRAINING COURSE Internal Auditor Training for ISO 9001 CERTIFIED QMS INTERNAL AUDITOR TRAINING COURSE See page 6 for Lead Auditor Training for ISO See page 5 for Internal Auditor Training for ISO Prepare to lead your own audits. This intensive 5-day course, presented largely through hands-on workshops, teaches you the skills you need to plan, conduct, and follow up on ISO 9001 compliance audits. Designed for first-, second-, and third-party auditors and professionals leading corporate ISO 9001 compliance activities. Also recommended for internal auditors seeking a deeper understanding of the audit process. There is a required 2-hour final exam. NOTES: This is an Exemplar Global certified course. See page 15 for full details. Exemplar Global requires that all attendees study the current published version of ISO 9001 before attending this class. $1995 Course Code: LAI 4.4 CEUs 5 Days JANUARY Chicago, IL JULY 9 13 Boston, MA FEB 26 MAR 2 Dallas, TX AUGUST 6 10 Raleigh, NC MARCH Edison, NJ SEPTEMBER Dallas, TX APRIL 9 13 Los Angeles, CA OCTOBER 1 5 Chicago, IL APR 30 MAY 4 Indianapolis, IN NOVEMBER Edison, NJ MAY Orlando, FL DECEMBER 3 7 Indianapolis, IN JUNE 4 8 Edison, NJ Find out how to develop, implement, and evaluate an internal audit system that meets the requirements of ISO 9001 and the needs of your organization. This course is a perfect fit if you will be conducting, managing, or participating in internal (first-party) audits or helping to develop an ISO 9001-compliant quality system. There is a required 1-hour final exam. NOTES: This is an Exemplar Global certified course. See page 15 for full details. Exemplar Global requires that all attendees study the current published version of ISO 9001 before attending this class. JANUARY 9 11 MARCH JUNE 5 7 AUGUST 7 9 OCTOBER $1295 Course Code: IAI 2.5 CEUs 3 Days Edison, NJ Chicago, IL Dallas, TX Edison, NJ Indianapolis, IN 9/18 THE CLOCK IS CLICKING. The final deadline for ISO 9001:2015 transition is SEPTEMBER 14, 2018! Transition to ISO 9001:2015 Assess the major changes in the new standard and discover how to use these changes as opportunities to make your quality management system (QMS) a strategic element of good performance and sustainability over time. Topics include: The ISO 9001:2015 standard a clause-by-clause review Evaluating and improving QMS performance Linking process metrics to key performance indicators (KPIs) The transition period and a recommended action plan Risk Management for ISO 9001:2015 Learn how to recognize risks, assess their impact on performance, and initiate mitigating actions to protect your organization. Unmanaged risks can have a devastating impact on financial performance, marketplace reputation, and the ability to retain customers or develop new markets. In today s environment, risk-based thinking must become an integral part of the organizational culture. During this course, you ll learn how to apply the principles in ISO 31000:2009 ( Risk management Principles and guidelines ), the risk reference standard for ISO These two courses run back-to-back. Take them together to learn more about (and get the most out of) the ISO 9001:2015 standard. $1295 Course Code: TRI 1.5 CEUs 2 Days JANUARY Los Angeles, CA APRIL 9 10 Dallas, TX FEBRUARY Raleigh, NC APR 30 MAY 1 Boston, MA FEBRUARY Chicago, IL MAY Orlando, FL MARCH Edison, NJ JUNE Edison, NJ MARCH Indianapolis, IN $1295 Course Code: RMI 1.5 CEUs 2 Days JANUARY Los Angeles, CA APRIL Dallas, TX FEBRUARY Raleigh, NC MAY 2 3 Boston, MA FEB 28 MAR 1 Chicago, IL MAY Orlando, FL MARCH Edison, NJ JUNE Edison, NJ MARCH Indianapolis, IN For additional dates and locations or to register

14 Instructor Spotlight Your instructor is the most important component of your training course get to know some of ours. Kate is outstanding. Her knowledge of and insight into industry trends are invaluable. Quality Engineer KATE LEITH Kate is VP of Training and Education for Oriel STAT A MATRIX. She has more than 25 years of experience in global quality, compliance, and training in the life sciences sector. Her expertise spans the total product life cycle, including design development, premarket quality, operations and supplier quality, and postmarket surveillance. Kate s dynamic training style ensures that course participants master the skills and knowledge being taught. Chad helped us address our 483 and efficiently implement corrective actions. CEO CHAD HEDLUND Chad is Sr. VP of Life Sciences Consulting and Education for Oriel STAT A MATRIX. He has 20 years of global regulatory experience focused in postmarket surveillance, MDR, complaint handling, adverse drug reporting, inspection readiness, CAPA, quality systems, and audit. Chad provides strategic oversight for the firm s life sciences practice and works closely with customers to address their quality and regulatory challenges ensuring that our solutions meet regulatory scrutiny while enhancing productivity and shareholder value. Carolyn was fabulous very knowledgeable and supported information with regulatory references and examples from the real world. Quality Manager CAROLYN TOMLINSON Carolyn is the Director of QMS Training at Oriel STAT A MATRIX. She brings more than 20 years of quality engineering experience in life sciences to the classroom. Her focus is on training related to QA, ISO 13485, FDA s QSR, CAPA, auditing, and performance excellence. Carolyn leverages her real-world experiences to ensure that students obtain a practical understanding of classroom topics. Richard s ability to pull from his vast experience enhanced my training. VP Regulatory Affairs Ed s a rock star. He brings a deep knowledge to the classroom, and made a dry topic interesting. Sr. Quality Director RICHARD VINCINS Richard is VP of Global Regulatory Affairs for Oriel STAT A MATRIX. He has 25+ years of global medical device, IVD, and pharmaceutical Quality Systems Regulation experience and expertise in submission content, regulatory classifications, risk management, software-driven products, postmarket surveillance, complaint handling, adverse event reporting, inspection readiness, and auditing. Richard is responsible for 30+ FDA 510(k) clearances across 10 different branches, and has been involved in EC certification for 62 tech files covering 30 project types, varying from Class I to III. ED SIUREK Ed is VP of Quality Systems for Oriel STAT A MATRIX. He has 25+ years of experience in quality standards, continuous improvement, facility and supplier audits, and regulatory compliance for pharmaceutical and medical device industries. Ed has supported life sciences organizations on 6 continents and in over 55 countries, giving him a unique perspective that he brings to each customer engagement. Lori is a great instructor my training was effective AND fun! Quality Engineer LORI KAHLER Lori is VP of US Regulatory Affairs for Oriel STAT A MATRIX. She has 25 years of global experience in RA/QA, with a broad background in regulatory, clinical, and quality assurance. Students cite Lori s extensive experience interacting with FDA and global regulators as being key to helping them master course content All of our courses can be delivered on-site

15 PGE HEAD REGISTRATION Registration Details REGISTRATION FEES Registration fees are due prior to the start of the course and include all course materials and lunch. Program schedules with start times will be sent with the registration confirmation. DISCOUNTS You may qualify for one of the discounts listed below. Offers may not be combined with any other discounts. Group Discount: Enroll 3 students in the same course (held on the same date and at the same location) at the regular price and receive a 4th enrollment for free. SUBSTITUTIONS, TRANSFERS, CANCELLATIONS POLICY Substitutions If you cannot attend a course, you may send an alternate person to attend in your place. You can make a substitution at any time, at no additional charge. us (details below) and tell us the alternate s name, the course name, and the session dates. Transfers and Cancellations You may transfer to a different course session (based on availability). Transfers and cancellations will be charged as follows: 22 or more days before the course start date: no charge days before the course start date: 25% of the tuition 7 14 days before the course start date: 50% of the tuition 6 or fewer days before the course start date: 100% of the tuition your requests for cancellations, transfers, or substitutions to customerservice@orielstat.com. A $25 service charge is applied to returned checks. NOTICE Oriel STAT A MATRIX prohibits tape or digital recordings of any sessions. Oriel STAT A MATRIX reserves the right to rearrange course content and is not responsible for typographical errors. Courses may be cancelled and locations may be changed at the discretion of Oriel STAT A MATRIX. Oriel STAT A MATRIX is not responsible for airfare, hotel, or other costs incurred by registrants. To ensure an optimal learning environment, Oriel STAT A MATRIX reserves the right to remove disruptive students and not provide a refund. COPYRIGHT Materials provided by Oriel STAT A MATRIX are protected by the Oriel STAT A MATRIX copyright, which will continue to belong exclusively to Oriel STAT A MATRIX. Inquiries regarding the purchase of additional course materials should be sent to customerservice@orielstat.com. POLICY Oriel STAT A MATRIX does not discriminate on the basis of race, national origin, religion, gender, age, or handicap in its policies, procedures, or practices. HOTEL INFORMATION All courses are scheduled at hotels. Locations are typically finalized days prior to the start of the course and are provided once the course is confirmed. EXEMPLAR GLOBAL CERTIFIED COURSES To attain registration as a QMS Auditor, QMS Senior Auditor, or QMS Lead Auditor, you must pass the written final examination, earn a passing grade in the course continuous assessments, and meet prescribed professional requirements, including a number of actual audits. Training courses presented as Exemplar Global certified courses meet the training requirements for certification of individual QMS Auditors, QMS Senior Auditors, and QMS Lead Auditors. Successful completion satisfies the training requirements for individual auditor certification under the qualification-based system offered by Exemplar Global. Registration Form FIVE EASY WAYS TO ENROLL IN A COURSE PHONE TOLL-FREE: FAX: MAIL (checks only): ONLINE: (for US and Canada) Select option , attn: Registration Dept. Oriel STAT A MATRIX 1095 Morris Avenue, Suite 103B, Union, NJ customerservice@orielstat.com Customer Information (please print) Name Title Company Address City State Zip Country Phone Ext. Fax Home phone (for emergencies only) Dietary requirements: Vegetarian Kosher Other Is this a confirmation of a telephone registration? Yes No Please tell us how we can best accommodate your needs. Course Selection and Location Course Code City Date(s) Course Fee Course Subtotal: Subtract discount, if applicable. Check applicable discount and enter figure below. Group Discount Subtract Discount: TOTAL AMOUNT DUE: Check enclosed for $ Please make check payable to Oriel STAT A MATRIX. Bill my purchase order # for $ Signature Date Bill my credit card (check one): Visa MasterCard American Express Please enter account #: Exp. date CVV (3- or 4-digit security code) Signature Date Credit card payments and purchase orders must be signed. Zip code for credit card billing address Corrections/Deletions: To make corrections or delete your name, fax entire page to We can only correct/delete names that appear on our house mailing list. For internal use only: Initial here Date For additional dates and locations or to register

16 1095 Morris Avenue, Suite 103B Union, NJ PRSRT STD U.S. POSTAGE PAID COLUMBUS, WI PERMIT NO. 73 Years of Excellence The Leaders in Medical Device Quality and Regulatory Training and Consulting WINTER SPRING 2018 Years of Excellence Practical, hands-on quality and regulatory training TRENDING FOR 2018! Transition to the EU s New Medical Device Regulation (MDR) PAGE 3 Transition to MDSAP PAGE 4 Transition to ISO 13845:2016 PAGE 5 ISO Lead Auditor Training PAGE 6 Risk Management / ISO PAGE 8 Complaint Handling, Vigilance Reporting, and Recall Management PAGE 9 FIND A CLASS THAT MEETS YOUR NEEDS