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Stay ahead of fast-moving quality and regulatory changes!

Years of Excellence

WWW.ORIELSTAT.COM | 800.472.6477

New and updated courses on MDSAP, the EU’s new Medical Device Regulation, ISO 13485:2016, and

ISO 14971. 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!

SPRING – SUMMER 2018

MEDICAL DEVICE RA/QA TRAINING

http://www.orielstat.com


Take your career to the next levelOriel 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.

STRATEGIC TACTICAL MONITORING

Our classes cover the following topics:

FOCUS ON:

Regulatory Changes and Overview

FOCUS ON:

QMS Auditing & Compliance

FOCUS ON:

QA/RA Process Optimization

Be proactive! Stay ahead

of critical changes to

medical device RA/QA

requirements.

Become a trusted

Subject Matter Expert

by mastering these

important areas.

Make sure you know

how to ensure your

organization stays

compliant.

Over

130,000QMS auditors

trained !

Medical Device Single Audit Program (MDSAP)2 days

p 5

ISO 13485:2016 Transition2 days

p 5

Design Control3 days

p 7

ISO 14971 Risk Management3 days

p 7UPDATED !

Complaint Handling3 days

p 9UPDATED !

Optimizing CAPA2 days

p 10

Performance-Based Auditing5 days

p 13

Software Validation2 days

p 9UPDATED !

Root Cause Analysis3 days

p 10

Process Validation Principles and Protocols3 days

p 12

Supplier Quality Management3 days

p 1 1

ISO 13485 Lead AuditorExemplar Global Certified

5 days

p 6

ISO 13485 Internal AuditorExemplar Global Certified

3 days

p 12

91% of the largest device

companies trust our training.

EU MDR 2017/745 Transition3 days

p 3NEW !

Foundation in ISO 13485 and QSR3 days

p 8UPDATED !

US & EU Device Submissions3 days

p1 1

SOP Writing and Process Mapping2 days

p 8NEW !

ISO 9001 Lead and Internal AuditorExemplar Global Certified p 13

Offered in 12 US cities, Europe,

and Costa Rica. On-site training is

also available.

EU MDR Transition Support

To learn more, call 800.472.6477

or email [email protected].

EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)

$2995 ■ Course Code: EMF ■ 2.5 CEUs ■ 3 Days

APRIL 9–11 Chicago, IL SEPTEMBER 10–12 Frankfurt, DE

MAY 14–16 Orlando, FL SEPTEMBER 10–12 Irvine, CA

MAY 21–23 Edison, NJ SEPTEMBER 17–19 Edison, NJ

MAY 28–30 Dublin, IE OCTOBER 1–3 Minneapolis, MN

JUNE 4–6 Minneapolis, MN OCTOBER 15–17 San Francisco Area, CA

JUNE 11–13 Frankfurt, DE OCTOBER 22–24 Austin, TX

JUNE 18–20 Boston, MA OCTOBER 29–31 Boston, MA

JULY 9–11 Chicago, IL NOVEMBER 12–14 Chicago, IL

JULY 23–25 San Diego, CA NOVEMBER 12–14 San José, Costa Rica

JUL 30–AUG 1 San José, Costa Rica NOVEMBER 19–21 Dublin, IE

AUGUST 13–15 Dublin, IE DECEMBER 3–5 Frankfurt, DE

AUGUST 13–15 Orlando, FL DECEMBER 3–5 Raleigh, NC

AUGUST 27–29 Indianapolis, IN DECEMBER 10–12 San Diego, CA

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 3 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.

TOPICS• 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

COURSE OBJECTIVES• 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.

WHO SHOULD ATTEND

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.

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.

NEW !

PGE HEADPGE HEAD MEDICAL DEVICE RA/QA

3For additional dates and locations or to register — 800.472.6477 — www.orielstat.com

mailto:info%40orielstat.com?subject=


2022 – 20252015 2016 2017 2018 2019 2020 2021

January 1, 2019CMDCAS certificates no longer valid.

MDSAP

EU MEDICAL DEVICE REGULATION (MDR)

May 26, 2020MDR compliance required for all new devices or recertification.

May 27, 2022MDD Annex IV certificates expire.

May 26, 2024All other MDD certificates expire.

EU IN VITRO DEVICE REGULATION (IVDR)

May 27, 2022IVDR compliance required for all new devices or recertification.

May 26, 2025All other IVDD certificates expire.

ISO 9001 : 2015

September 14, 2018ISO 9001:2008 certifications no longer valid.

November 30, 2018Upgrade audit should be complete.

ISO 13485 : 2016

February 28, 2019ISO 13485:2003 certifications no longer valid.

KEY TRANSITION DATES

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 [email protected] or 800.472.6477 to learn more.

Multiple transition deadlines demand timely action from medical device manufacturers.

! Deadlines 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.


You have until March 2019 to update your

current ISO 13485 certification to ISO 13485:2016.MARCH 2019

COURSE OBJECTIVES• Describe the background, drivers, and transition period for the

ISO 13485:2016 standard.• Describe the relationship of ISO 13485 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.

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.

TOPICS• 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

WHO SHOULD ATTEND

Anyone engaged in the implementation or auditing of their organization’s quality management system.

ISO 13485:2016 Medical Device QMS Transition Training

$1995 ■ Course Code: TNF ■ 1.5 CEUs ■ 2 Days

APRIL 16–17 Chicago, IL AUGUST 13–14 San Francisco Area, CA

APRIL 23–24 Edison, NJ AUGUST 20–21 Orlando, FL

APR 30–MAY 1 San Francisco Area, CA SEPTEMBER 17–18 Boston, MA

MAY 7–8 Orlando, FL OCTOBER 1–2 Raleigh, NC

JUNE 4–5 Indianapolis, IN OCTOBER 8–9 San Diego, CA

JUNE 11–12 Minneapolis, MN OCTOBER 22–23 Edison, NJ

JUNE 25–26 Chicago, IL OCTOBER 29–30 Indianapolis, IN

JULY 16–17 Irvine, CA OCTOBER 29–30 San José, Costa Rica

JULY 23–24 San José, Costa Rica NOVEMBER 12–13 Minneapolis, MN

JULY 30–31 Edison, NJ DECEMBER 3–4 Boston, MA

Medical Device Single Audit Program (MDSAP) Training

$2495 ■ Course Code: SAF ■ 1.5 CEUs ■ 2 Days

APRIL 11–12 San Diego, CA AUGUST 15–16 San Francisco Area, CA


MAY 2–3 San Francisco Area, CA SEPTEMBER 19–20 Boston, MA

MAY 9–10 Orlando, FL SEPTEMBER 26–27 Minneapolis, MN

MAY 16–17 Boston, MA OCTOBER 3–4 Raleigh, NC

JUNE 6–7 Indianapolis, IN OCTOBER 10–11 San Diego, CA

JUNE 13–14 Minneapolis, MN OCTOBER 17–18 Chicago, IL

JUNE 20–21 San Diego, CA OCTOBER 24–25 Edison, NJ

JUNE 27–28 Chicago, IL OCT 31–NOV 1 Indianapolis, IN

JULY 11–12 Austin, TX OCT 31–NOV 1 San José, Costa Rica

JULY 18–19 Irvine, CA NOVEMBER 7–8 Orlando, FL

JULY 25–26 San José, Costa Rica NOVEMBER 7–8 San Francisco Area, CA

AUGUST 1–2 Edison, NJ NOVEMBER 14–15 Minneapolis, MN

AUGUST 8–9 Indianapolis, IN DECEMBER 5–6 Boston, MA

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 2019.

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.

TOPICS• 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• The MDSAP Nonconformity Grading Tool• Quality Plan Template: Prepare for MDSAP Participation

Health Canada will require MDSAP certification by January 2019 – are you ready?

WHO SHOULD ATTEND

Anyone engaged in their organization’s quality management system, regulatory compliance, QA/QC, and internal auditing.

COURSE OBJECTIVES• 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.

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).

MEDICAL DEVICE RA/QA

5www.orielstat.com — 800.472.6477 — All of our courses can be delivered on-site


Lead Auditor Training for ISO 13485

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 19011 while providing a sector-focused learning experience for those engaged in the medical device industry.

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 13485 before attending this class.

Over 130,000 auditors trained in ISO 13485, ISO 9001, and related standards since 1990!

TOPICS• Interpretation and use of ISO 13485:2016• The audit cycle and ISO 19011• 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

WHO SHOULD ATTEND

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.

COURSE OBJECTIVES

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 13485 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.

$2695 ■ Course Code: LAF ■ 4.4 CEUs ■ 5 Days

APRIL 16–20 San Diego, CA JULY 16–20 San José, Costa Rica OCTOBER 8–12 Edison, NJ

APR 30–MAY 4 Chicago, IL JULY 23–27 Austin, TX OCTOBER 15–19 San Diego, CA

MAY 7–11 Orlando, FL JUL 30–AUG 3 Raleigh, NC OCTOBER 22–26 Minneapolis, MN

MAY 14–18 San Francisco Area, CA AUGUST 6–10 Chicago, IL OCTOBER 22–26 San José, Costa Rica

JUNE 4–8 Edison, NJ AUGUST 13–17 Orlando, FL OCT 29–NOV 2 Chicago, IL

JUNE 11–15 Indianapolis, IN AUGUST 20–24 San Francisco Area, CA NOVEMBER 5–9 Orlando, FL

JUNE 18–22 Boston, MA SEPTEMBER 17–21 Boston, MA NOVEMBER 12–16 San Francisco Area, CA

JUNE 25–29 San Diego, CA SEPTEMBER 24–28 Irvine, CA DECEMBER 3–7 Edison, NJ

JULY 9–13 Minneapolis, MN OCTOBER 1–5 Indianapolis, IN DECEMBER 10–14 Indianapolis, IN

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 800.472.6477 or email

[email protected].

MOVE BEYOND CONFORMANCE with an Oriel STAT A MATRIX AUDIT

Audit Report

Audit satisfactory

Observations made

Nonconformances foundCERTIFIED QMS LEAD AUDITOR TRAINING COURSE

6 www.orielstat.com — 800.472.6477 — All of our courses can be delivered on-site




Implementing Design Control Requirements and Best Practices

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.

WHO SHOULD ATTEND

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.

TOPICS• 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

COURSE OBJECTIVES• 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.

$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 10–12 Chicago, IL NOVEMBER 28–30 Boston, MA

AUGUST 7–9 Edison, NJ DECEMBER 11–13 San Diego, 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

ISO 14971 Medical Device Risk Management Training

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.

WHO SHOULD ATTEND

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.

COURSE OBJECTIVES• 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 62304 and the

application of ISO 14971 to software (ISO/TR 80002-1).• 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.

TOPICS• 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

$2895 ■ Course Code: RMF ■ 2.5 CEUs ■ 3 Days

MAY 1–3 Orlando, FL AUGUST 14–16 San Diego, CA

MAY 15–17 Minneapolis, MN SEPTEMBER 11–13 Minneapolis, MN

JUNE 5–7 Chicago, IL SEPTEMBER 25–27 Boston, MA

JUNE 12–14 Boston, MA OCTOBER 9–11 Chicago, IL

JULY 10–12 San Diego, CA OCTOBER 23–25 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

UPDATED !

Risk management isn’t just about risk. There is another side to the equation – BENEFIT!




TOPICS• FDA QSR background and subpart review compared against ISO 13485

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

WHO SHOULD ATTEND

This course is appropriate for anyone who needs to understand how to meet the requirements of a global medical device quality system.

COURSE OBJECTIVES• 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

UPDATED !

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 13485 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.

$2495 ■ Course Code: GRF ■ 2.5 CEUs ■ 3 Days

APRIL 24–26 Edison, NJ SEPTEMBER 18–20 Orlando, FL

MAY 1–3 Orlando, FL SEPTEMBER 25–27 San Diego, CA

MAY 22–24 San Diego, CA OCTOBER 9–11 Chicago, IL

JUNE 5–7 Chicago, IL OCTOBER 23–25 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 14–16 Boston, MA NOVEMBER 14–16 San José, Costa Rica

SEPTEMBER 11–13 Edison, NJ NOVEMBER 27–29 Indianapolis, IN

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).

COURSE OBJECTIVES

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 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!

TOPICS• Documentation requirements (global regulations and standards)• Technical writing, process mapping, and error proofing• Electronic records• Change control requirements

WHO SHOULD ATTEND

Recommended for staff members involved in preparing plans, procedures, and instructions as part of a document management system.

Documentation management strategies for the 21st century

$1995 ■ Course Code: DOF ■ 1.5 CEUs ■ 2 Days

MAY 30–31 Orlando, FL

AUGUST 1–2 Chicago, IL

OCTOBER 3–4 Boston, MA

DECEMBER 5–6 San Diego, CA

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

NEW !




COURSE OBJECTIVES• 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.

• 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.

TOPICS• The SDLC, including examples of

commonly used SDLCs• Verification and validation• Key regulations/standards/

guidance, including IEC 62304, AAMI TIR36, ISO/TR 80002-2, and AAMI TIR45

• Risk management processes and risk-based validation

• Design control and software validation guidance

• Testing level strategies (unit, integration, system, user)

• 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

WHO SHOULD ATTEND

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.

Software Verification and Validation Requirements

Recently updated content includes a greater focus on

IEC 62034 (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.

Medical Device Vigilance Training: Complaint Investigation and

Reporting, Postmarket Surveillance, Recall Management

WHO SHOULD ATTEND

Anyone who needs to understand and apply the regulatory requirements for complaint handling and event reporting.

TOPICS• 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 14971 and linkages with corrections, removals, and recalls

• Postmarket surveillance requirements: ISO 13485:2016, US FDA, EU Medical Device Regulation, and Canada

• Audit preparation

$2895 ■ Course Code: CHF ■ 2.5 CEUs ■ 3 Days

MAY 8–10 Edison, NJ AUGUST 21–23 Edison, NJ

MAY 15–17 Chicago, IL SEPTEMBER 11–13 Indianapolis, IN

MAY 22–24 San Diego, CA OCTOBER 2–4 San Diego, CA

JUNE 12–14 Boston, MA OCTOBER 16–18 Chicago, IL

JULY 10–12 Minneapolis, MN OCT 30–NOV 1 Orlando, FL

JULY 24–26 Orlando, FL NOVEMBER 13–15 Minneapolis, MN

AUGUST 7–9 San Francisco Area, CA DECEMBER 11–13 Boston, MA

UPDATED !UPDATED !

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.

COURSE OBJECTIVES

At the end of this course, participants will be able to:• Describe key regulatory

requirements for handling complaints, vigilance, and field actions.

• Identify best practices for structuring the complaint-handling process and the Complaint-Handling Unit.

• Perform complaint intake, triage, investigation, and closure.

• Describe the role of risk management and CAPA in effective complaint handling.

• Identify reporting requirements in the EU, China, and MDSAP countries.

• Apply a risk-based approach to needed corrections and removals.

• Identify postmarket surveillance requirements, including those in the EU Medical Device Regulation.

• Explain how to prepare for audits of the complaint-handling system, including FDA, Notified Body, and MDSAP.

$2495 ■ Course Code: SVF ■ 1.5 CEUs ■ 2 Days


JULY 9–10 San Diego, CA

SEPTEMBER 10–11 Boston, MA

NOVEMBER 1–2 Minneapolis, MN




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.

Optimizing CAPA Programs for the Medical Device Industry

COURSE OBJECTIVES • 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.

• 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.

WHO SHOULD ATTEND

Recommended for top management, management representatives, and staff in:• Compliance/regulatory affairs• QA/QC• Manufacturing operations• CAPA management

• Information systems/technology• Document management• Distribution• Research and development

$1995 ■ Course Code: CAF ■ 1.5 CEUs ■ 2 Days


MAY 7–8 Chicago, IL SEPTEMBER 24–25 San Diego, CA

JUNE 5–6 San Francisco Area, CA OCTOBER 15–16 Minneapolis, MN

JUNE 19–20 Indianapolis, IN NOVEMBER 28–29 Edison, NJ

JUL 31–AUG 1 Boston, MA DECEMBER 4–5 Chicago, IL

TOPICS

• What is CAPA and when is it required?

• CAPA program pitfalls and best practices

• Risk-based decision making for corrections and removals

• Elements of effective CAPA: roles, inputs, and metrics

• CAPA methodology: from problem definition to effectiveness checks

• Basic root cause analysis• CAPA communication

Root Cause Analysis for Life Science Investigations

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 problem-closing culture that allows organizations to both solve and recover from problems more quickly, applying project management in RCA, and documenting the root cause investigations.

TOPICS• 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

COURSE OBJECTIVES• 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.

WHO SHOULD ATTEND

This course is a good fit for anyone from the medical device, biotech, and pharmaceutical industries participating in root cause analysis investigations.

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!

$2895 ■ Course Code: RCF ■ 2.5 CEUs ■ 3 Days

MAY 9–11 Chicago, IL

SEPTEMBER 26–28 San Diego, CA

OCTOBER 17–19 Minneapolis, MN

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




Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark]

$2895 ■ Course Code: WSF ■ 2.5 CEUs ■ 3 Days

MAY 15–17 San Diego, CA

JUNE 26–28 Orlando, FL

AUGUST 21–23 Minneapolis, MN

OCTOBER 23–25 Edison, NJ

$2895 ■ Course Code: SQF ■ 2.5 CEUs ■ 3 Days


MAY 15–17 Minneapolis, MN

JUNE 12–14 San Francisco Area, CA

JULY 10–12 Boston, MA

JUL 31–AUG 2 Chicago, IL

AUG 28–30 Edison, NJ

SEPTEMBER 18–20 San Diego, CA

NOVEMBER 5–7 Orlando, FL

DECEMBER 11–13 Minneapolis, MN

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.

TOPICS • 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

WHO SHOULD ATTEND

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.

Is the 510(k) appropriate for my device?

When am I allowed to affix a CE Mark?

COURSE OBJECTIVES • 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.

How can you get your product to market in the US or 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 morequickly, more efficiently, and with greater chances of success. Call 800.472.6477 or email [email protected] to learn more.

Supplier Quality Management: Designing a Successful Program

COURSE OBJECTIVES• 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.

TOPICS• 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

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.

WHO SHOULD ATTEND

Designed for personnel involved in sourcing, securing, and maintaining suppliers and services who ensure excellent product quality and organizational reputation.

Warning letter citations related to purchasing controls

have more than doubled in the past 5 years.





$2895 ■ Course Code: PVF ■ 2.5 CEUs ■ 3 Days

MAY 8–10 Edison, NJ AUGUST 21–23 Edison, NJ

MAY 22–24 Orlando, FL SEPTEMBER 18–20 San Francisco Area, CA

JUNE 12–14 Minneapolis, MN OCTOBER 2–4 Orlando, FL

JUNE 19–21 San Diego, CA OCTOBER 16–18 Minneapolis, MN

JULY 24–26 Boston, MA OCT 30–NOV 1 San Diego, CA

AUGUST 7–9 Chicago, IL NOVEMBER 13–15 Chicago, IL

AUGUST 14–16 Indianapolis, IN DECEMBER 11–13 Boston, MA

Process Validation Principles and Protocols

WHO SHOULD ATTEND

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.

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.

COURSE OBJECTIVES• 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.

TOPICS

• 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 13485 process validation requirements

• The validation master plan• Installation qualification (IQ)• Operational qualification (OQ)• Performance qualification (PQ)

Internal Auditor Training for ISO 13485

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.

COURSE OBJECTIVES• 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 19011.

• 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.

TOPICS• The quality management system• Analysis and interpretation of

ISO 13485• Process and risk-based auditing

techniques • The quality audit cycle

• Preaudit activities• On-site audit activities• Report writing and nonconformity

reports• Corrective action and audit follow-up

WHO SHOULD ATTEND

This is a perfect fit if you will be conducting, managing, or participating in internal (first-party) audits or helping to develop an ISO 13485-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.


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.

$1995 ■ Course Code: IAF ■ 2.5 CEUs ■ 3 Days

APRIL 24–26 Orlando, FL AUGUST 7–9 San Diego, CA

MAY 8–10 Minneapolis, MN SEPTEMBER 5–7 Boston, MA

MAY 22–24 San Francisco Area, CA OCTOBER 2–4 Orlando, FL

JUNE 19–21 Edison, NJ NOVEMBER 13–15 Indianapolis, IN

JULY 17–19 Chicago, IL DECEMBER 11–13 Minneapolis, MN

CERTIFIED QMS INTERNAL AUDITOR TRAINING COURSEHow confident are you that your processes

have the controls in place to produce safe

and effective products? 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




Performance-Based Auditing: A Tool for FDA’s Case for Quality

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.

Calling all experienced auditors!

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.


See page 12 for Internal Auditor Training for ISO 13485.

Internal Auditor Training for ISO 9001

$1295 ■ Course Code: IAI ■ 2.5 CEUs ■ 3 Days

JUNE 5–7 Dallas, TX

JUNE 19–21 Minneapolis, MN

AUGUST 7–9 Edison, NJ

OCTOBER 23–25 Indianapolis, IN

CERTIFIED QMS INTERNAL AUDITOR TRAINING COURSE

Lead Auditor Training for ISO 9001

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.


$1995 ■ Course Code: LAI ■ 4.4 CEUs ■ 5 Days

APR 30–MAY 4 Indianapolis, IN SEPTEMBER 10–14 Dallas, TX

MAY 14–18 Orlando, FL OCTOBER 1–5 Chicago, IL

JUNE 4–8 Edison, NJ NOVEMBER 12–16 Edison, NJ

JULY 9–13 Boston, MA DECEMBER 3–7 Indianapolis, IN

AUGUST 6–10 Raleigh, NC

See page 6 for Lead Auditor Training for ISO 13485.

CERTIFIED QMS LEAD AUDITOR TRAINING COURSE

$2995 ■ Course Code: PBF ■ 4 CEUs ■ 5 Days

MAY 14–18 San Diego, CA

JULY 16–20 Edison, NJ

SEPTEMBER 17–21 Chicago, IL

NOVEMBER 5–9 Boston, MA

COURSE OBJECTIVES• 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).

TOPICS• 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

• Planning, conducting, and reporting a performance-based audit

• Linkages between the process approach to auditing and key performance indicators (KPIs)

• Measuring audit program effectiveness

WHO SHOULD ATTEND

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.

130,000 and COUNTING!

Oriel STAT A MATRIX has been training auditors longer than any other training organization in the world.



Your instructor is the most important component of your training course – get to know some of ours.

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 HEDLUNDChad 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.

RICHARD VINCINSRichard 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 SIUREKEd 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 KAHLERLori 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.

Instructor Spotlight

CAROLYN TOMLINSONCarolyn 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.

Kate is outstanding. Her knowledge of and insight into industry trends are invaluable.”

– Quality Engineer

Chad helped us address our 483 and efficiently implement corrective actions.”

– CEO

Carolyn was fabulous – very knowledgeable and supported information with regulatory references and examples from the real world.”

– Quality Manager

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

Lori is a great instructor – my

training was effective AND fun! ”– Quality Engineer



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. Email 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• 15–21 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

Email your requests for cancellations, transfers, or substitutions to [email protected].

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 [email protected].

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 21–28 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.

FIVE EASY WAYS TO ENROLL IN A COURSE

PHONE TOLL-FREE: 800.472.6477 (for US and Canada)

732.548.0600. Select option 1.

FAX: 732.626.6084, attn: Registration Dept.

MAIL (checks only): Oriel STAT A MATRIX

1095 Morris Avenue, Suite 103B, Union, NJ 07083

EMAIL: [email protected]

ONLINE: www.orielstat.com/training

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The Leaders in Medical Device Quality and Regulatory Training and ConsultingYears of

Excellence

Stay ahead of fast-moving medical device

quality and regulatory changes with

training from Oriel STAT A MATRIX

SPRING – SUMMER 2018

MEDICAL DEVICE RA/QA TRAINING CATALOG

• 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

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