MEDICAL DEVICE RA/QA TRAINING Stay ahead of fast-moving quality and regulatory changes!

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1 SPRING SUMMER 2018 Years of Excellence MEDICAL DEVICE RA/QA TRAINING Stay ahead of fast-moving quality and regulatory changes! New and updated courses on MDSAP, the EU s new Medical Device Regulation, ISO 13485:2016, and ISO Choose from one of 19 classes offered in 12 US cities, Europe, and Costa Rica each taught by experienced instructors in an unmatched hands-on format that s been fine-tuned over 50 years!

2 Take your career to the next level Oriel STAT A MATRIX has been training QA/RA professionals for 50 years. Our classes are packed with information but small in size, so you have plenty of opportunities to ask questions. After spending 2 5 days with our team, you ll walk out the door more confident and with greater knowledge than when you arrived. Our classes cover the following topics: FOCUS ON: Regulatory Changes and Overview STRATEGIC TACTICAL MONITORING Be proactive! Stay ahead of critical changes to medical device RA/QA requirements. EU MDR 2017/745 Transition NEW! p 3 Medical Device Single Audit Program (MDSAP) 2 days p 5 ISO 13485:2016 Transition 2 days p 5 91% of the largest device companies trust our training. Become a trusted Subject Matter Expert by mastering these important areas. ISO Risk Management UPDATED! Design Control p 7 p 7 SOP Writing and Process Mapping 2 days NEW! p 8 Software Validation 2 days UPDATED! p 9 Make sure you know how to ensure your organization stays compliant. ISO Lead Auditor Exemplar Global Certified 5 days p 6 Over 130,000 QMS auditors trained! Complaint Handling UPDATED! p 9 Optimizing CAPA 2 days p 10 FOCUS ON: QMS Auditing & Compliance Foundation in ISO and QSR UPDATED! p 8 Root Cause Analysis p 10 ISO Internal Auditor Exemplar Global Certified p 12 FOCUS ON: QA/RA Process Optimization US & EU Device Submissions p11 Supplier Quality Management p 11 ISO 9001 Lead and Internal Auditor Exemplar Global Certified p 13 Offered in 12 US cities, Europe, and Costa Rica. On-site training is also available. Process Validation Principles and Protocols p 12 Performance- Based Auditing 5 days p 13

3 PGE HEAD NEW! EU MDR Transition Training (Europe s Medical Device Regulation 2017/745) 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, 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 $2995 Course Code: EMF 2.5 CEUs 3 Days APRIL 9 11 Chicago, IL SEPTEMBER Frankfurt, DE MAY Orlando, FL SEPTEMBER Irvine, CA MAY Edison, NJ SEPTEMBER Edison, NJ MAY Dublin, IE OCTOBER 1 3 Minneapolis, MN JUNE 4 6 Minneapolis, MN OCTOBER San Francisco Area, CA JUNE Frankfurt, DE OCTOBER Austin, TX JUNE Boston, MA OCTOBER Boston, MA JULY 9 11 Chicago, IL NOVEMBER Chicago, IL JULY San Diego, CA NOVEMBER San José, Costa Rica JUL 30 AUG 1 San José, Costa Rica NOVEMBER Dublin, IE AUGUST Dublin, IE DECEMBER 3 5 Frankfurt, DE AUGUST Orlando, FL DECEMBER 3 5 Raleigh, NC AUGUST Indianapolis, IN DECEMBER San Diego, CA MEDICAL DEVICE RA/QA EU MDR Transition Support Early compliance to the EU MDR will provide manufacturers with a significant competitive advantage. Changes required to attain compliance to the new Regulation are significant. Coupled with well-documented shortages for Notified Body resources, this means that organizations that move quickly on their transitions will be better positioned to secure NB resources and maintain access to EU markets opening the door for an opportunity to grow market share in this significant sector. Get started on your transition with an EU MDR Transition Assessment. We ll conduct a series of Workstream Assessments on the areas impacted by the new Regulation and conclude with a comprehensive EU MDR 2017/745 Transition Quality Plan that documents an actionable roadmap detailing tasks and resources required to transition your organization to the new Regulation. Oriel STAT A MATRIX has been assisting medical device manufacturers with regulatory and quality system conformance for 50 years. Our experience supporting medical device manufacturers at every step from achieving compliance with global regulations to making processes more effective and efficient, thus improving business results will ensure that your organization is successful in its EU MDR 2017/745 transition. To learn more, call or info@orielstat.com. For additional dates and locations or to register

4 ! Deadlines Multiple transition deadlines demand timely action from medical device manufacturers. for ISO 9001:2015 (page 13), MDSAP (page 5), 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.

5 MEDICAL DEVICE RA/QA Medical Device Single Audit Program (MDSAP) Training MARCH 2019 You have until March 2019 to update your current ISO certification to ISO 13485:2016. 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 MDSAP-participating 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. MDSAP objectives MDSAP roles and responsibilities The MDSAP audit model and audit process Health Canada will require MDSAP certification by January 2019 are you ready? 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. The nonconformity grading matrix Preparing for the MDSAP Anyone engaged in their organization s quality management system, regulatory compliance, QA/QC, and internal auditing. HIGHLIGHTED HANDOUTS MDSAP Audit Checklist The MDSAP Nonconformity Grading Tool Quality Plan Template: Prepare for MDSAP Participation $2495 Course Code: SAF 1.5 CEUs 2 Days APRIL San Diego, CA AUGUST San Francisco Area, CA APRIL Edison, NJ AUGUST Orlando, FL MAY 2 3 San Francisco Area, CA SEPTEMBER Boston, MA MAY 9 10 Orlando, FL SEPTEMBER Minneapolis, MN MAY Boston, MA OCTOBER 3 4 Raleigh, NC JUNE 6 7 Indianapolis, IN OCTOBER San Diego, CA JUNE Minneapolis, MN OCTOBER Chicago, IL JUNE San Diego, CA OCTOBER Edison, NJ JUNE Chicago, IL OCT 31 NOV 1 Indianapolis, IN JULY Austin, TX OCT 31 NOV 1 San José, Costa Rica JULY Irvine, CA NOVEMBER 7 8 Orlando, FL JULY San José, Costa Rica NOVEMBER 7 8 San Francisco Area, CA AUGUST 1 2 Edison, NJ NOVEMBER Minneapolis, MN AUGUST 8 9 Indianapolis, IN DECEMBER 5 6 Boston, MA ISO 13485:2016 Medical Device QMS Transition Training Updates include discussions on ISO 13485:2016 s relationship with MDSAP (page 5) and the EU s new Medical Device Regulation (EU 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 APRIL Chicago, IL AUGUST San Francisco Area, CA APRIL Edison, NJ AUGUST Orlando, FL APR 30 MAY 1 San Francisco Area, CA SEPTEMBER Boston, MA MAY 7 8 Orlando, FL OCTOBER 1 2 Raleigh, NC JUNE 4 5 Indianapolis, IN OCTOBER 8 9 San Diego, CA JUNE Minneapolis, MN OCTOBER Edison, NJ JUNE Chicago, IL OCTOBER Indianapolis, IN JULY Irvine, CA OCTOBER San José, Costa Rica JULY San José, Costa Rica NOVEMBER Minneapolis, MN JULY Edison, NJ DECEMBER 3 4 Boston, MA 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. EXEMPLAR GLOBAL REGISTRATION REQUIREMENTS 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 APRIL San Diego, CA JULY San José, Costa Rica OCTOBER 8 12 Edison, NJ APR 30 MAY 4 Chicago, IL JULY Austin, TX OCTOBER San Diego, CA MAY 7 11 Orlando, FL JUL 30 AUG 3 Raleigh, NC OCTOBER Minneapolis, MN MAY San Francisco Area, CA AUGUST 6 10 Chicago, IL OCTOBER San José, Costa Rica JUNE 4 8 Edison, NJ AUGUST Orlando, FL OCT 29 NOV 2 Chicago, IL JUNE Indianapolis, IN AUGUST San Francisco Area, CA NOVEMBER 5 9 Orlando, FL JUNE Boston, MA SEPTEMBER Boston, MA NOVEMBER San Francisco Area, CA JUNE San Diego, CA SEPTEMBER Irvine, CA DECEMBER 3 7 Edison, NJ JULY 9 13 Minneapolis, MN OCTOBER 1 5 Indianapolis, IN DECEMBER Indianapolis, IN All of our courses can be delivered on-site

7 MEDICAL DEVICE RA/QA UPDATED! ISO Medical Device Risk Management Training Implementing Design Control Requirements and Best Practices Risk management isn t just about risk. There is another side to the equation BENEFIT! The new EU Medical Device Regulation emphasizes using state of the art in assessing benefit. FDA expects the same. Using interactive hands-on workshops and group discussions, students in this recently updated course learn to evaluate whether risks and benefits are appropriately balanced to ensure compliance and optimal patient outcomes. During this course students will cover 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. The course also delves into new topics like risk management expectations in MDSAP and the new EU Medical Device Regulation, as well as risk management for software (both in devices and as devices) and related cybersecurity risks. Identify integration of risk into the new EU MDR, MDSAP, and the US FDA perspective. Describe the ISO 14971:2007 standard s structure, supporting standards, key concepts, and trends. Evaluate EN ISO 14971:2012 content deviations and potential changes leading toward consensus in the EU Medical Device Regulation. Identify software risk management expectations in IEC and the application of ISO to software (ISO/TR ). Create a risk management plan, apply tools for risk assessment and risk control, conduct a risk-benefit analysis, and create a risk management report. Conduct a post-production risk assessment and postmarket surveillance. Global regulatory compliance requirements for risk management, including EU and MDSAP ISO 14971: its purpose, clauses, content deviations, and move toward consensus Requirements for each step of the risk management process, including risk management plan, risk analysis, risk evaluation, risk control, risk-benefit, risk management file, and post-production analyses Post-production risk management requirements, including reactive CAPA activities and proactive postmarket surveillance Recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, and regulatory affairs professionals; and other cross-functional team members in a medical device environment. $2895 Course Code: RMF 2.5 CEUs 3 Days MAY 1 3 Orlando, FL AUGUST San Diego, CA MAY Minneapolis, MN SEPTEMBER Minneapolis, MN JUNE 5 7 Chicago, IL SEPTEMBER Boston, MA JUNE Boston, MA OCTOBER 9 11 Chicago, IL JULY San Diego, CA OCTOBER Indianapolis, IN JUL 31 AUG 2 Edison, NJ NOVEMBER 6 8 Edison, NJ AUGUST 7 9 Orlando, FL DECEMBER 4 6 San Francisco Area, CA 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 APRIL 3 5 Boston, MA SEPTEMBER 5 7 Orlando, FL MAY 1 3 Minneapolis, MN OCTOBER 2 4 San Francisco Area, CA JUNE 5 7 San Diego, CA OCT 30 NOV 1 Minneapolis, MN JULY Chicago, IL NOVEMBER Boston, MA AUGUST 7 9 Edison, NJ DECEMBER San Diego, CA For additional dates and locations or to register

8 MEDICAL DEVICE RA/QA UPDATED! 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. QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 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 5) and FDA s Case for Quality (page 13). Who needs to know about QSR and ISO 13485? Everyone. If you are new to RA/QA a solid foundation ensures your success. If you re experienced in RA/QA regulations are rapidly changing, you don t want to get left behind. If you re in management ISO 13485:2016 mandates that management understands these requirements. By taking this course, you ll gain an understanding of the basic requirements for FDA s Quality System Regulation (QSR), ISO 13485:2016, and more. Through engaging classroom discussions, workshops, and activities, you will follow a product s life cycle to explore how different elements of ISO and FDA s QSR should be implemented at each 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. 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. $2495 Course Code: GRF 2.5 CEUs 3 Days APRIL Edison, NJ SEPTEMBER Orlando, FL MAY 1 3 Orlando, FL SEPTEMBER San Diego, CA MAY San Diego, CA OCTOBER 9 11 Chicago, IL JUNE 5 7 Chicago, IL OCTOBER San Francisco Area, CA JUL 31 AUG 2 Minneapolis, MN OCT 30 NOV 1 Minneapolis, MN AUGUST 1 3 San José, Costa Rica NOVEMBER 6 8 Boston, MA AUGUST Boston, MA NOVEMBER San José, Costa Rica SEPTEMBER Edison, NJ NOVEMBER Indianapolis, IN NEW! 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 of 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. MAY AUGUST 1 2 OCTOBER 3 4 DECEMBER 5 6 SOP Writing and Process Mapping for Medical Device Regulations (ISO 13485, MDSAP, EU MDR) Excellent explanation and interpretation of requirements in understandable language. Quality Manager $1995 Course Code: DOF 1.5 CEUs 2 Days Orlando, FL Chicago, IL Boston, MA San Diego, CA All of our courses can be delivered on-site

9 MEDICAL DEVICE RA/QA Medical Device Vigilance UPDATED! Training: Complaint Investigation and Reporting, Postmarket Surveillance, Recall Management Updates include the new EU Regulation s postmarket surveillance requirements (page 3), and vigilance reporting requirements from China, the EU, and all five MDSAP countries (page 5). 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 decision making, 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 MAY 8 10 Edison, NJ AUGUST Edison, NJ MAY Chicago, IL SEPTEMBER Indianapolis, IN MAY San Diego, CA OCTOBER 2 4 San Diego, CA JUNE Boston, MA OCTOBER Chicago, IL JULY Minneapolis, MN OCT 30 NOV 1 Orlando, FL JULY Orlando, FL NOVEMBER Minneapolis, MN AUGUST 7 9 San Francisco Area, CA DECEMBER Boston, MA $2495 Course Code: SVF 1.5 CEUs 2 Days 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 APRIL Edison, NJ AUGUST Orlando, FL MAY 7 8 Chicago, IL SEPTEMBER San Diego, CA JUNE 5 6 San Francisco Area, CA OCTOBER Minneapolis, MN JUNE Indianapolis, IN NOVEMBER Edison, NJ JUL 31 AUG 1 Boston, MA DECEMBER 4 5 Chicago, IL 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 Chicago, IL San Diego, CA Minneapolis, MN 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 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. 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. 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. MAY JUNE AUGUST OCTOBER $2895 Course Code: WSF 2.5 CEUs 3 Days San Diego, CA Orlando, FL Minneapolis, MN Edison, NJ MAY 1 3 $2895 Course Code: SQF 2.5 CEUs 3 Days Orlando, FL MAY Minneapolis, MN JUNE San Francisco Area, CA JULY Boston, MA JUL 31 AUG 2 Chicago, IL AUG Edison, NJ SEPTEMBER San Diego, CA NOVEMBER 5 7 Orlando, FL DECEMBER Minneapolis, MN For additional dates and locations or to register

12 MEDICAL DEVICE RA/QA Process Validation Principles and Protocols 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 MAY 8 10 Edison, NJ AUGUST Edison, NJ MAY Orlando, FL SEPTEMBER San Francisco Area, CA JUNE Minneapolis, MN OCTOBER 2 4 Orlando, FL JUNE San Diego, CA OCTOBER Minneapolis, MN JULY Boston, MA OCT 30 NOV 1 San Diego, CA AUGUST 7 9 Chicago, IL NOVEMBER Chicago, IL AUGUST Indianapolis, IN DECEMBER Boston, MA Internal Auditor Training for ISO 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 CERTIFIED QMS INTERNAL AUDITOR TRAINING COURSE 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 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 APRIL Orlando, FL AUGUST 7 9 San Diego, CA MAY 8 10 Minneapolis, MN SEPTEMBER 5 7 Boston, MA MAY San Francisco Area, CA OCTOBER 2 4 Orlando, FL JUNE Edison, NJ NOVEMBER Indianapolis, IN JULY Chicago, IL DECEMBER Minneapolis, MN 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. Performance-Based Auditing: A Tool for FDA s Case for Quality Calling all experienced auditors! 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 performance-based auditing: More robust methodologies for preparing and conducting audits Auditor competence Enhanced audit criteria that consider efficiency and effectiveness Applied statistics for auditing $2995 Course Code: PBF 4 CEUs 5 Days San Diego, CA Edison, NJ Chicago, IL Boston, MA MAY JULY SEPTEMBER NOVEMBER 5 9 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. Lead Auditor Training for ISO 9001 See page 6 for Lead 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 APR 30 MAY 4 Indianapolis, IN SEPTEMBER Dallas, TX MAY Orlando, FL OCTOBER 1 5 Chicago, IL JUNE 4 8 Edison, NJ NOVEMBER Edison, NJ JULY 9 13 Boston, MA DECEMBER 3 7 Indianapolis, IN AUGUST 6 10 Raleigh, NC Internal Auditor Training for ISO 9001 See page 12 for Internal Auditor Training for ISO 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. JUNE 5 7 JUNE AUGUST 7 9 OCTOBER CERTIFIED QMS LEAD AUDITOR TRAINING COURSE CERTIFIED QMS INTERNAL AUDITOR TRAINING COURSE $1295 Course Code: IAI 2.5 CEUs 3 Days Dallas, TX Minneapolis, MN Edison, NJ 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 MEDICAL DEVICE RA/QA TRAINING CATALOG SPRING SUMMER 2018 Classes updated to reflect changes in ISO 13485, EU s new MDR, MDSAP Conveniently offered in 12 US cities, Europe, and Costa Rica 91% of top medical device companies are training with us! Over 130,000 QMS auditors trained Stay ahead of fast-moving medical device quality and regulatory changes with training from Oriel STAT A MATRIX