years of training catalog 2020 - oriel stat a...
TRANSCRIPT
Years of Excellence
OVER
All classes are available as Virtual Instructor-Led Training!
*Oriel STAT A MATRIX is an Exemplar Global Registered Training Provider. See page 15 for more information.
AUDITOR TRAININGLead Auditor Training for ISO 13485 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Internal Auditor Training for ISO 13485 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Updated! Internal Auditing to MDSAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3New! Conducting a Remote Medical Device QMS Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4EU MDR Auditor Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5New! EU IVDR Auditor Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
REGULATORY CHANGES & OVERVIEW TRAININGCER (Clinical Evaluation Report) Training for EU MDR Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Implementing the EU’s New Medical Device Regulation Training (MDR 2017/745) . . . . . . . . . . . . . . . . . . . 5Implementing the EU’s New In Vitro Diagnostic Regulation Training (IVDR 2017/746) . . . . . . . . . . . . . . . . . . . . 6QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
RA/QA PROCESS OPTIMIZATION TRAININGISO 14971 Medical Device Risk Management Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Medical Device Complaint Handling, Event Reporting, and Recall Management Training . . . . . . . . . . . . . . . . 8New! Medical Device Postmarket Surveillance (PMS) Implementation Training . . . . . . . . . . . . . . . . . . . . . . 8Process Validation Training for Medical Devices: Principles and Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Design Control Training for Medical Devices: Requirements and Best Practices . . . . . . . . . . . . . . . . . . . . . . 9Medical Device CAPA Training: Optimizing Your Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Medical Device Root Cause Analysis Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Medical Device Supplier Quality Management Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
DIGITAL HEALTH TRAININGSoftware Development, Verification, and Validation Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11New! Managing Medical Device Cybersecurity Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12New! Medical Device Data Integrity and 21 CFR Part 11 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
WINTER– SPRING2021
TRAINING CATALOG
Certified Auditor Training*
INSTRUCTOR SPOTLIGHT 13 REGISTRATION
DETAILS 15
Expert instruction, engaging class discussions, and workshops use ISO 13485:2016 as the primary audit criteria. Workshops reinforce key topics with hands-on practice opportunities. Our course teaches the audit discipline according to ISO 19011:2018, the standard for auditing quality management systems, while providing a sector-focused learning experience for professionals in the medical device industry.
During this class, go through every phase of an audit, so you will be able to lead audits against the ISO 13485 standard efficiently and effectively.
Lead Auditor Training for ISO 13485
BEST SELLER !
At a Glance
Learn how to lead an ISO 13485 audit and the entire audit process by participating in a simulated audit .
REGISTERED TRAINING PROVIDER
EXEMPLAR GLOBAL REGISTERED TRAINING PROVIDEROriel STAT A MATRIX is a Registered Training Provider for Exemplar Global . Students who achieve a passing grade on the course’s final exam will earn a certificate recognized by Exemplar Global as evidence of your competency, and an Oriel STAT A MATRIX credential in assessing proficiency. See page 15 for more information.
COURSE REQUIREMENTSAll attendees must study the current published version of ISO 13485 before attending class. Evening
study recommended. A 2-hour final exam is required. For virtual classes, the exam is administered
online, during the final class.
WHAT YOU WILL LEARNAt the end of this workshop, you will have learned:• Interpretation and use of ISO 13485:2016 as audit criteria• The audit cycle and ISO 19011:2018• 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 ATTENDThis course was originally designed to
train third-party auditors, but most
attendees lead their company’s QMS
implementation and/or audit programs.
Ideal for anybody involved in a supplier
quality assurance program who has
auditing experience and/or has
completed an internal auditor course.
JANUARY 11–21 1ST WEEK: January 11–15 2ND WEEK: January 18–21
FEBRUARY 1–11 1ST WEEK: February 1–5 2ND WEEK: February 8–11
FEBRUARY 22–MARCH 4 1ST WEEK: February 22–26 2ND WEEK: March 1–4
MARCH 15–25 1ST WEEK: March 15–19 2ND WEEK: March 22–25
APRIL 12–22 1ST WEEK: April 12–16 2ND WEEK: April 19–22
MAY 10–20 1ST WEEK: May 10–14 2ND WEEK: May 17–20
JUNE 7–17 1ST WEEK: June 7–11 2ND WEEK: June 14–17
JULY 12–22 1ST WEEK: July 12–16 2ND WEEK: July 19–22
AUGUST 9–19 1ST WEEK: August 9–13 2ND WEEK: August 16–19
SEPTEMBER 13–23 1ST WEEK: September 13–17 2ND WEEK: September 20–23
Week 1: Daily 1:00–5:00 PM ET Week 2: M-W 1:00–5:00 PM, TH 11:30 AM–5:00 PM ET
$2895 ■ Course Code: LAF ■ 4.4 CEUs
VIRTUAL INSTRUCTOR-LED ■ 9 HALF-DAYS
Oriel STAT A MATRIX is known for our in-person workshops and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes . Our instructors and students interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment.
Open Enrollment Virtual Seminars We offer a full calendar of classes to choose from. Visit orielstat.com/training for our latest schedule .
NOTE: All open enrollment classes run daily from 1:00–5:00 PM Eastern time (ET). Certified auditor classes start at 11:30 AM on the final day to allow extra time to administer the final exam.
This convenient half-day format allows you to balance your other responsibilities while still getting the training you need .
Private Virtual Seminars An ideal solution if you’re looking to train 5 or more. Delivery times are flexible, and content can be tailored to meet your organization’s unique needs.
The high level of interaction in the virtual classroom kept all of the participants engaged and made for a great learning experience . ”
VIRTUALINSTRUCTOR-LED TRAINING
The same great training from the convenience of your home or office
For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events2
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.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• 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
EXEMPLAR GLOBAL REGISTERED TRAINING PROVIDER Oriel STAT A MATRIX is a Registered Training Provider for Exemplar Global . Students who achieve a passing grade on the course’s final exam will earn a certificate recognized by Exemplar Global as evidence of your competency, and an Oriel STAT A MATRIX credential in assessing proficiency. See page 15 for more information.
EXEMPLAR GLOBAL CERTIFIED TPECS PROVIDER FOR THE QM-MDSAP COMPETENCY UNITOriel STAT A MATRIX is the first Exemplar Global Certified Provider for the Quality Management – MDSAP Competency Unit under their Training Provider and Examiner Certification Scheme (TPECS). Successful demonstration of the required competency earns you a Certificate of Attainment for the QM-MDSAP Competency Unit that you can use as independent evidence of your internal auditors’ readiness to support and sustain MDSAP compliance. See page 15 for more information.
COURSE REQUIREMENTSAll attendees should study the current published version of ISO 13485
before attending class. Evening study is recommended during the course.
A 1-hour final exam is required. For virtual classes, the exam is
administered online, during the final class.
WHO SHOULD ATTENDThis 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.
REGISTERED TRAINING PROVIDER
WHO SHOULD ATTENDThis is an advanced auditing course and participants are expected to have
hands-on experience in medical device internal auditing and a working
knowledge of ISO 13485:2016.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Examine MDSAP as a system audit, compliance audit, product audit,
and process audit• Identify requirements for auditing technical documentation and
sterilization processes• Review MDSAP processes, tasks, outcomes, linkages, and nonconformity
grading• Analyze device regulations in MDSAP jurisdictions: Australia, Brazil,
Canada, Japan, and the US• Review the intent and guidance for ISO 13485:2016 interpretation• Evaluate objective evidence using a case study approach to simulate an
MDSAP internal audit• Apply a risk-based approach to designing the internal audit program• Evaluate strategies for aligning the internal audit program to MDSAP
Designed especially for experienced auditors, this intensive class will
teach you how to apply the process-based approach and align your current
internal audit program to the MDSAP requirements. We also take a
detailed look at country-specific requirements for the five MDSAP
participant markets: Australia, Brazil, Canada, Japan, and the United
States, and have added a review of the impact of MDSAP on the affiliate
markets: Argentina and Republic of Korea.
$1995 ■ Course Code: IAF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
February 8–12May 3–7
August 2–6November 8–12
The first 4 days run 1:00–5:00 PM ET; the final session runs 11:30 AM-5:00 PM ET to allow time for administering the final exam.
$2995 ■ Course Code: AMF ■ 2.8 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 25–29 June 14–18February 22–26 July 12–16
March 22–26 August 9–13April 19–23 September 13–17May 17–21
The first 4 days run 1:00–5:00 PM ET; the final session runs 11:30 AM–5:00 PM ET to allow time for administering the final exam.
Internal Auditing to MDSAP
CERTIFIED TPECS PROVIDER FOR THE QM-MDSAP COMPETENCY UNIT
At a Glance
Learn how to audit using the MDSAP process-based approach and the unique requirements for each participating country.
UPDATED !
At a Glance
Learn how to monitor compliance with ISO 13485:2016. Simulates a real audit to help you prepare to conduct your own audits .
This course reflects the recently revised MDSAP Audit Approach document!
33For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
WHO SHOULD ATTEND Medical device professionals who have practical experience in internal or
external auditing.
RECOMMENDED PREREQUISITEOriel STAT A MATRIX courses ISO 13485:2016 Lead Auditor Training or
ISO 13485:2016 Internal Auditor Training or equivalent.
Conducting a Remote Medical Device QMS Audit
WHAT YOU WILL LEARNAt the conclusion of this workshop, you will be able to:• Explain why a remote/virtual audit can be both valid and effective• Explain the role of risk analysis when using remote audits• Plan a remote audit• Identify potential issues when performing remote audits• Identify best practices for performing remote audits
Remote auditing is not new. However, the COVID-19 pandemic has
put them in the spotlight as organizations are looking for solutions to
keep their audit programs on track while “shelter in place”
requirements are in place.
Virtual audits are perfectly acceptable and, beyond the obvious
benefits for addressing social distancing, over the long term can be a
tool organizations leverage to save time and expenses while
improving efficiency.
Designed for experienced auditors, in this class we’ll teach you how to
effectively complete all phases of the audit process in a remote
format. We’ll also explore common challenges of a virtual audit and
ways to overcome them.
NEW !
REGISTERED TRAINING PROVIDER
At a Glance
Learn how to navigate an audit in a remote context .
$1095 ■ Course Code: RAF ■ 0.8 CEUs
VIRTUAL INSTRUCTOR-LED ■ 2 HALF-DAYS
January 5–6February 1–2March 29–30May 17–18
July 6–7September 7–8
Daily 1:00–5:00 PM Eastern time
EXEMPLAR GLOBAL REGISTERED TRAINING PROVIDER Oriel STAT A MATRIX is a registered training provider for Exemplar Global . Students who pass the course requirements will earn both a certificate recognized by Exemplar Global as evidence of your competency as well as an Oriel STAT A MATRIX credential in assessing proficiency.
WHO SHOULD ATTEND Anyone working in regulatory, quality, risk management, or clinical roles
with responsibility for creating, reviewing, or auditing CERs. Participants
are expected to have some basic knowledge of clinical evaluation reports,
risk management, and medical device regulation in the EU.
WHAT YOU WILL LEARNAt the conclusion of this workshop, you will be able to:• Identify clinical evaluation report components related to EU MDR and
MEDDEV 2.7/1 rev. 4 • Explain the relationship of CERs to MDR 2017/745, MEDDEV 2.7/1 rev. 4,
EN ISO 13485:2016, and EN ISO 14971:2012• Describe the relationship of clinical evidence to clinical data and clinical
evaluation• Understand the five stages of clinical evaluation under MEDDEV 2.7/1
rev. 4 and their role in the product life cycle• Explain how clinical data is employed to support device purpose and use• Understand the clinical investigation requirements under EU MDR and
rationale for when it is not needed• Create a clinical evaluation plan in compliance with EU MDR and
MEDDEV 2.7/1 rev. 4• Describe data collection processes and types, including the use of
nonclinical data• Understand “state of the art” with linkage to benefit-risk analysis• Conduct data analysis using clinical literature as well as safety and
performance data• Create a PMCF plan for the CER and integrate postmarket surveillance
and benefit-risk analysis
This training class will walk you through all aspects of assembling a CER
from the ground up as well as improving your existing clinical evaluation to
meet the more stringent requirements of the new EU MDR. Using
workshops and real-life examples, your instructor will address all facets
of clinical data, clinical evidence, and clinical investigations, explaining
the requirements for each and detailing all five stages of the clinical
evaluation process.
At a Glance
Learn all aspects of clinical evaluation – from planning to postmarket clinical follow-up – so your CERs can withstand Notified Body scrutiny.
$3495 ■ Course Code: ECF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 11–15 June 7–11February 8–12 July 12–16
March 8–12 August 16–20April 5–9 September 20–24
May 10–14Daily 1:00–5:00 PM Eastern time
CER (Clinical Evaluation Report) Training for EU MDR Compliance
44For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
EU MDR (2017/ 745) FOCUSED CLASSES
WHO SHOULD ATTENDInternal regulatory and QMS auditors, audit-related personnel, and those
performing gap assessments to the new EU MDR.
PREREQUISITESParticipants are expected to have practical experience in auditing,
awareness of the EU MDR, and a working knowledge of ISO 13485:2016 and
EN ISO 14971:2012.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Understand the drivers, intent, and impact of the EU MDR• Articulate the relationship between the EU MDR, ISO 13485:2016, and
CEN/TR 17223:2018• Craft a plan for how to conduct EU MDR gap assessments and perform a
comprehensive audit• Evaluate objective evidence using a case study approach to simulate an
internal audit to the EU MDR• Explain the relationship to MDSAP and FDA audits and differences
between them• Gain a solid understanding of how to audit to specific EU MDR
requirements, with emphasis on the following areas: – Technical documentation, including clinical data and risk management files – Product classification and conformity assessment route – Postmarket surveillance processes – QMS and ISO 13485:2016 compliance – Unique Device Identification and traceability requirements
REGISTERED TRAINING PROVIDER
EU MDR Auditor Training
This interactive, case study-based training prepares you to audit to
EU Medical Device Regulation requirements using real-life examples.
BEST SELLER !
At a Glance
Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements.
EXEMPLAR GLOBAL REGISTERED TRAINING PROVIDER Oriel STAT A MATRIX is a Registered Training Provider for Exemplar Global . Students who achieve a passing grade on the course’s final exam will earn a certificate recognized by Exemplar Global as evidence of your competency, as well as Oriel STAT A MATRIX credentials in assessing proficiency. See page 15 for more information.
$3295 ■ Course Code: LEF ■ 2.8 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 11–15 June 14–18February 8–12 July 19–23
March 8–12 August 16–20April 12–16 September 20–24May 10–14
The first 4 days run 1:00–5:00 PM ET; the final session runs 11:30 AM–5:00 PM ET to allow time for administering the final exam.
WHO SHOULD ATTENDAnyone who works for manufacturers that market medical devices
in the EU.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Describe the objectives and structure of the MDR• Identify key new requirements in the MDR related to device
classification, conformity assessment routes, quality management
systems, technical documentation, clinical evaluation, UDI,
postmarket surveillance and reporting, and Notified Body audits• Understand and explain the impact of the new MDR requirements on
economic operators, including manufacturers• Identify the necessary steps for preparing an organization to
transition to the MDR• Conduct a gap assessment as part of transitioning to the new
requirements
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, 2021 transition deadline. This
course is a critical first step.
In this class, you will learn about the new requirements in the EU 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.
BEST SELLER !
At a Glance
Learn key changes between the MDD and MDR, how to make the transition, and best practices for transitioning .
Implementing the EU’s New Medical Device Regulation Training (MDR 2017/745)
$2995 ■ Course Code: EMF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 11–15February 15–19
March 22–26April 26–30May 24–28June 21–25August 2–6
September 13–17Daily 1:00–5:00 PM Eastern time
55For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
EU IVDR (2017/ 746) FOCUSED CLASSES
WHO SHOULD ATTENDInternal and corporate auditors, personnel participating in audits, and
those performing gap assessments to the new EU IVDR. Participants are
expected to have practical experience in auditing, awareness of the EU
IVDR, and a working knowledge of ISO 13485 and ISO 14971.
The clock is ticking for In Vitro Diagnostic (IVD) manufacturers. If you are
a manufacturer who conducts business in the EU, you must start your
transition now in order to meet the May 26, 2022 transition deadline. Your
internal auditors will be critical resources in the transition. This course
uses a case-study approach to prepare participants to audit to the EU IVDR.
It is designed for auditors with experience auditing to ISO 13485 but will
also help auditor-facing personnel prepare for Notified Body audits.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Understand the drivers, requirements, intent, and impact of the EU IVDR• Evaluate the justification for risk-based device classification and
conformity routes• Identify the requirements for economic operators, PRRC, and the role of
common specifications• Assess the EU IVDR impact on quality management system requirements.• Determine the relationship of EU IVDR requirements to 13485:2016
using CEN/TR 17223:2018• Evaluate EU IVDR requirements related to risk management, GSPRs,
technical documentation, UDI, performance evaluation, and postmarket
surveillance• Evaluate objective evidence, build audit checklists, and devise auditor
questions while using a case study approach to simulate an internal
audit to EU IVDR
EXEMPLAR GLOBAL REGISTERED TRAINING PROVIDEROriel STAT A MATRIX is a Registered Training Provider for Exemplar Global . Students who achieve a passing grade on the course’s final exam will earn a certificate recognized by Exemplar Global as evidence of your competency, as well as Oriel STAT A MATRIX credentials in assessing proficiency. See page 15 for more information.
At a Glance
Designed for experienced auditors who need to perform internal and supplier audits to the EU IVDR requirements.
$3295 ■ Course Code: LIF ■ 2.8 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 18–22March 1–5
April 26–30June 21–25August 2–6
September 27–October 1The first 4 days run 1:00–5:00 PM ET; the final session runs
11:30 AM–5:00 PM ET to allow time for administering the final exam.
Implementing the EU’s New In Vitro Diagnostic Regulation Training (IVDR 2017/746)
WHO SHOULD ATTENDAnyone who works for manufacturers that market in vitro diagnostics
in the EU.
The changes under Europe’s new IVD regulation are significant, including
the need for Notified Body involvement, a greatly expanded definition of
what is considered an IVDR, a new risk-based IVD classification system,
increased clinical evidence requirements, new quality system mandates,
and more rigorous postmarket scrutiny. IVD manufacturers who conduct
business in the EU must start their transition now in order to meet the
May 26, 2022 transition deadline.
In this class, you’ll learn about the new requirements found in the IVDR,
their impact on manufacturers, and how to plan an effective and efficient
transition to the IVDR.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Describe IVDR objectives and structure and identify key differences
between the IVDD and IVDR• Explain the impact of the new IVDR requirements on economic
operators, including manufacturers• Describe the various regulatory requirements through the life cycle
of a device• Explain new stipulations for the clinical evaluation process and risk
management, including performance evaluation• Understand new device classification rules plus technical
documentation, UDI, and traceability specifications• Articulate postmarket surveillance and reporting mandates in the IVDR• Identify the steps needed to prepare an organization to transition to
the IVDR• Plan a gap assessment to transition an organization to compliance
and understand the impact on internal auditing
At a Glance
Learn key changes between the IVDD and IVDR, how to make the transition, and best practices for transitioning .
$3195 ■ Course Code: EIF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 25–29March 8–12April 19–23May 24–28July 19–23
August 30–September 3Daily 1:00–5:00 PM Eastern time
EU IVDR Auditor Training
NEW !
REGISTERED TRAINING PROVIDER
66For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
QMS Training for Medical Devices: FDA QSR and ISO 13485:2016
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.
• 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
WHAT YOU WILL LEARNAt the conclusion of this workshop, you will be able to:• Describe the objectives, requirements, and alignment of ISO 13485:2016
and FDA’s QSR, including the interrelationships among the quality
management system (QMS), resource management, management
responsibility, product realization, measurement analysis, and
improvement • Identify common elements found in global QMS requirements• Apply a risk-based approach to the QMS• 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
Who needs to know about QSR and ISO 13485?
Everyone!
At a Glance
Understand the basic requirements of FDA’s QSR and ISO 13485:2016 – “QMS 101.”
$2495 ■ Course Code: GRF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 11–15February 15–19
March 22–26April 26–30June 7–11July 12–16
August 16–20September 20–24
Daily 1:00–5:00 PM Eastern time
WHAT YOU WILL LEARNAt the conclusion of this workshop, you will be able to:• Understand global regulatory compliance requirements for risk
management (EU MDR, MDSAP, US FDA)• Describe the purpose, structure, and key concepts of ISO 14971 and
ISO/TR 24971, including the new definitions for benefit, state of the art,
and reasonably foreseeable misuse and the expanded requirements for
production and postproduction activities• Understand the relationship of ISO 13485, IEC 60601, IEC 62304,
IEC 62366, and ISO 10993 to ISO 14971• Articulate the requirements for each step of the risk management process• Create a risk management plan, apply tools for risk assessment and risk
control, conduct a benefit-risk analysis, create a risk management report,
and assess production and postproduction information for possible action• Identify software risk management expectations in IEC 62304, including
the application of ISO 14971 to software (ISO/TR 80002-1) and current
US FDA guidances for cybersecurity and SaMD• Understand production and postproduction risk management
requirements, including reactive CAPA activities and proactive
postmarket surveillance processes• Describe how to use the process and risk-based approaches of ISO 13485
to ensure the continued suitability, adequacy, and effectiveness of your
risk management process
ISO 14971 Medical Device Risk Management Training
The EU MDR, the MDSAP audit model, and ISO 14971:2019 have put a spotlight
on risk management as a foundational process in your QMS. How companies
manage device risk throughout the product life cycle is getting more scrutiny
from regulators and Notified Bodies than ever before.
Through interactive workshops and group discussions, course participants
learn to apply the ISO 14971 risk management process requirements
from planning through analysis and control to review, production, and
postproduction activities, including benefit-risk analysis. We also delve into
risk management aspects of software, SaMD, and cybersecurity.
WHO SHOULD ATTENDDesign managers and engineers; manufacturing, service, quality
assurance, reliability, research and development, regulatory affairs
professionals; and other cross-functional team members.
All attendees must have a basic familiarity with ISO 13485.
$2995 ■ Course Code: RMF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 18–22 May 17–21February 1–5 June 21–25
February 15–19 July 26–30March 15–19 August 23–27April 19–23 September 27–October 1
Daily 1:00–5:00 PM Eastern time
At a Glance
Learn to apply ISO 14971 risk management process requirements through the full device life cycle .
77For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
Medical Device Complaint Handling, Event Reporting, and Recall Management Training
Regulatory investigations and third-party audits often begin by examining
complaint data, because its appropriate management is essential to an
effective QMS. Given newly accelerated timelines for reporting events of
harm or potential harm in the EU and other countries – as well as an
increased focus by US FDA – efficient complaint identification,
investigation, and decision making has never been more critical.
Using a hands-on learning approach, you’ll work through the complete
complaint-handling process: intake, triage, investigation, closure or
escalation, recall management, and reporting. At the end of the class,
you’ll have the skills needed to increase effectiveness and efficiency
throughout the complaint-handling process.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Assess customer feedback scenarios using the FDA definition and
ISO 13485:2016 criteria to correctly identify alleged deficiencies, complaints,
and potentially reportable events, and write effective problem statements• Discuss complaint-handling unit strategies and best practices to
better integrate the function within the organization, measure its
effectiveness, and add value to management review• Analyze complaint investigations to accurately determine appropriate
next steps• Discuss post-production risk evaluation team formation, applicable
forms, tools, timing, necessary information, and impact assessment• Use a global reportability matrix to decide full reportability obligations
for events • Prepare for an audit of the complaint-handling system by
understanding and interpreting the reporting requirements in the US,
EU, and MDSAP countries• Apply a risk-based approach to needed corrections and removals by
practicing the risk assessment process leading to a recall decision• Identify postmarket surveillance requirements, including those in the
new EU MDR
At a Glance
Understand the global requirements for complaint handling and event reporting with a focus on the US, EU and the new EU MDR, and MDSAP countries .
$2995 ■ Course Code: CHF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 25–29 June 21–25March 8–12 July 26–30April 12–16 August 30–September 3May 17–21
Daily 1:00–5:00 PM Eastern time
Medical Device Postmarket Surveillance (PMS) Implementation Training
WHO SHOULD ATTENDMedical device professionals involved in postmarket surveillance, complaint
handling, incident reporting, and regulatory compliance. Others who play
a role in a manufacturer’s PMS process – such as importers, distributors,
and reprocessors connected to manufacturing processes – will also benefit.
PREREQUISITEParticipants should have experience with or basic knowledge of quality
management systems for the medical device industry. Virtual session
participants may also be required to complete a short eLearning module
covering basic topics related to the new EU medical device requirements.
Regulatory bodies are increasing their focus on postmarket surveillance
(PMS), as evidenced by the expanded requirements of the EU MDR and IVDR
and the establishment of PMS as a core process within the MDSAP program.
In this class, you will learn and practice practical steps for collecting,
analyzing, reporting, and applying postmarket data, as well as how to
connect the PMS process to QMS and risk management processes.
Using the ISO/TR 20416:2020 guidance as a foundation, gain knowledge
and skills for establishing and maintaining a medical device postmarket
surveillance system that not only provides inputs to systems that conform
to ISO 13485:2016 and ISO 14971:2019 but also satisfies the regulatory
requirements of EU MDR and IVDR, MDSAP, and other country-specific
stipulations.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Clearly define medical device PMS in your organization, and explain the
purpose of the postmarket surveillance process within the context of
your quality and risk management systems• Discuss in detail conformance to country-specific postmarket
surveillance regulatory requirements, including the EU MDR and IVDR• Identify and build needed linkages between your PMS process and QMS
and risk management processes• Create a PMS plan based on related regulatory requirements and the
ISO 13485:2016 and ISO 14971:2019 standards• Use ISO/TR 20416:2020 guidance to establish a process to identify,
gather, assess, and analyze postmarket surveillance data• Prepare a framework for postmarket surveillance reporting
At a Glance
Understand how to implement a PMS process aligned with ISO/TR 20416:2020 that meets EU MDR, EU IVDR, and MDSAP requirements.
$1995 ■ Course Code: PSF ■ 1.6 CEUs
VIRTUAL INSTRUCTOR-LED ■ 4 HALF-DAYS
February 23–26 August 10–13April 20–23 October 5–8June 15–18
Daily 1:00–5:00 PM Eastern time
WHO SHOULD ATTENDQuality and regulatory managers in medical device companies or anyone
who needs to understand and apply the regulatory requirements for
complaint handling and event reporting. All attendees must have a basic
familiarity with FDA 21 CFR Part 820 and ISO 13485.
NEW !
88For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
WHO SHOULD ATTENDRecommended 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.
The FDA and ISO 13485:2016 require process validation but don’t offer
much guidance. Through interactive discussions and workshops, 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.
You’ll also evaluate real-world process validation examples and warning
letters, as well as learn best practices for the practical application of
process validation in medical device manufacturing.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Explain the purpose of process validation, understand its life cycle, and
describe key concepts needed to successfully conduct process
validations• Identify the available guidelines and sources of requirements• Create a validation master plan (VMP)• Explain the intent of installation qualification (IQ), operational
qualification (OQ), and performance qualification (PQ)• Describe the requirements for IQ, OQ, and PQ and create associated
protocols• Identify and manage sources of variation in measurement systems• Articulate the role of quality management systems, metrology and
measurements systems, risk management, and quality tools and
analysis in process validation
Process Validation Training for Medical Devices: Principles and Protocols
At a Glance
Understand the planning and practical application of tools used in process validation . Learn by doing!
Design controls are integrated management practices applied to the
medical device development process, ensuring that the resulting device is
safe, effective, and meets stakeholder requirements. The pace of change
and the iterative nature of most design processes makes understanding
when and how to apply design controls even more important.
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 regulatory requirements, including MDSAP
(Medical Device Single Audit Program).
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. Attendees must
have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Identify design control requirements related to FDA, EU MDR, MDSAP,
and ISO 13485• Describe the design review, design verification, and design validation
processes• Evaluate the links between design, usability, and risk management• Understand the pros and cons of the linear and iterative processes and
the approach to systems design• Identify strategies for risk-based sampling and statistical justification• Describe best practices for the design transfer process• Practice the design control process in workshops, building a design
history file (DHF)• Describe postmarket surveillance and input to design changes• Identify FDA requirements and MDSAP outcomes and linkages related to
the design and development process in preparing for audits
Design Control Training for Medical Devices: Requirements and Best Practices
At a Glance
Learn the process of design control, from establishing and verifying inputs to managing change .
$2995 ■ Course Code: PVF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 25–29March 15–19April 26–30June 14–18July 26–30
September 13–17Daily 1:00–5:00 PM Eastern time
$2995 ■ Course Code: DBF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 18–22March 1–5April 5–9
May 10–14June 14–18July 19–23
August 23–27September 27–October 1
Daily 1:00–5:00 PM Eastern time
99For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
Every RA/QA manager has struggled with repeat CAPAs. A problem you
thought had been solved pops up again months later, but why? Persistent
problems are not only annoying, they can endanger patient safety, cost
money, and steer internal focus away from other issues.
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).
WHO SHOULD ATTENDRecommended for management and staff in compliance/regulatory
affairs, QA/QC, manufacturing operation, and document management.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Explain CAPA methodology, including roles, inputs, and metrics/sources
of data• Learn best practices for how to integrate your CAPA program into your
quality system• Understand FDA’s and other regulatory officials’ expectations for “what
CAPA is” and the steps required to get you there• Learn how CAPA can positively impact the bottom line• 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• Perform basic root cause analysis, including problem definition and
effectiveness checks
Medical Device CAPA Training:Optimizing Your Programs
At a Glance
Learn the elements of an effective CAPA program and best practices for optimizing your program.
Medical Device Root Cause Analysis Training
Root cause analysis (RCA) is the essential investigation method used by RA/
QA professionals to understand failures throughout a product’s life cycle.
Often conclusions are drawn too quickly and problems resurface months
later, affecting your time management, costing you money, and putting
patient safety at risk.
Using workshops, case studies, and simulations, in this course you’ll work
through the entire root cause analysis process, from creating a data-based
problem statement, applying RC tools, and conducting data analysis for
verifying the cause to selecting the best solution and determining its
effectiveness. The goal: Create a problem-closing culture that allows your
organization to both solve and recover from problems more quickly, apply
project management in RCA, and document the root cause investigations.
WHO SHOULD ATTENDThis course is a good fit for anyone from the medical device industry
participating in root cause analysis investigations.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Properly define the scope of a problem and localize it• Create an effective problem statement• Gain insight into strategies for selecting problems based on risk
and impact• Choose appropriate methods of investigation (brainstorm, affinity
diagram, 5 Whys, tree diagrams, cause and effect, and Is/IsNot)• Recognize the most appropriate data collection and analysis
strategy• Accurately define a problem, perform meaningful data analysis,
select a solution selection, verify effectiveness, and manage
the project• Understand and apply the tools for successful root cause analysis• Employ best practices for creating effective teams and monitoring
their progress• Verify root causes, properly document investigations, and audit
the results
ASK US ABOUT CUSTOMIZING THIS COURSE FOR YOUR COMPANY
Take real problems from your organization through the root cause investigation process!
At a Glance
Understand your obligations under 21 CFR Part 11 and why this area is so important to FDA.
$1995 ■ Course Code: CAF ■ 1.6 CEUs
VIRTUAL INSTRUCTOR-LED ■ 4 HALF-DAYS
February 8–11May 3–6July 6–9
October 18–21Daily 1:00–5:00 PM Eastern time
1010For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
Medical Device Supplier Quality Management Training
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Identify requirements for supplier quality management, including
ISO 13485:2016, US FDA, MDSAP, and the EU MDR• Establish a risk-based process for evaluating, selecting, and reevaluating
your suppliers• Translate needs into purchased product and supplier requirements• Develop and maintain an Approved Supplier List and manage your
outsourced processes• Understand the elements of a good quality agreement and when they are
needed• Implement an effective process for verifying purchased product and
monitoring ongoing supplier performance• Manage supplier nonconformances, escalation of issues, and supplier
change notification• Create clear product specifications and head off potential issues before
they occur• Identify and resolve supplier issues before they escalate
Poorly designed and executed supplier quality management systems can
cost your company millions. With dozens or hundreds of suppliers to
manage, you need a proven risk-based process that meets FDA
and ISO 13485:2016 requirements, plus new mandates found in
the EU Medical Device Regulation (MDR 2017/745). On paper, the
requirements seem straightforward, but applying them can get tricky.
You’ll walk away from this training with a clear understanding of the
various regulatory requirements and how to establish an effective and
efficient system using a risk-based approach.
WHO SHOULD ATTENDAnyone involved in sourcing, securing, and maintaining critical suppliers
and services that affect product quality and organizational reputation.
Attendees must have a basic familiarity with FDA 21 CFR Part 820 and
ISO 13485.
At a Glance
Learn best practices and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system .
WHO SHOULD ATTENDRecommended for computer system/software users, mid-level managers,
software developers/engineers/testers, product managers, regulatory
personnel, and quality assurance professionals in FDA-regulated fields.
US FDA and international regulatory standards relating to software are
evolving and becoming 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 validation of medical
device software, including embedded software, software as a medical
device (SaMD), and QMS software.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Understand key regulations/standards/guidance, including IEC 62304,
AAMI TIR36, ISO/TR 80002-2, and AAMI TIR45• 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 Agile software development aligns with regulatory
expectations for software validation• Identify requirements for validating nonproduct software (QMS software)• Describe how to apply risk management principles and perform
risk-based software tool validation• Assess real-world lessons learned and identify the benefits of an SDLC,
including time to market• Understand FDA design control guidance, including traceability and
design review requirements• Evaluate and recommend testing-level strategies (unit, integration,
system, user)• Understand methods development and documentation requirements• Create a plan for configuration and change management, including
defects and issues management• Describe documentation requirements for FDA and EU premarket
submissions
Medical Device Software Development, Verification, and Validation Training
At a Glance
Learn how to satisfy US and global regulatory requirements for the design and validation of software in devices .
$2995 ■ Course Code: SQF ■ 2.5 CEUs
VIRTUAL INSTRUCTOR-LED ■ 5 HALF-DAYS
January 25–29March 22–26
June 28–July 2August 23–27November 1–5
Daily 1:00–5:00 PM Eastern time
$2695 ■ Course Code: SVF ■ 1.6 CEUs
VIRTUAL INSTRUCTOR-LED ■ 4 HALF-DAYS
January 18–21 May 24–27February 22–25 June 28–July 1
March 29–April 1 August 2–5April 26–29 September 7–10
Daily 1:00–5:00 PM Eastern time
1111For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
WHO SHOULD ATTENDRecommended for risk managers, quality assurance professionals, auditors,
engineers/testers, product managers and regulatory professionals working
in medical device and in vitro diagnostic organizations.
Medical device cybersecurity is called out specifically in ISO 14971:2019 and
ISO/TR 24971:2020. This training will introduce you to the process of ensuring
that cybersecurity risks in connected devices are identified and managed
throughout the software lifecycle. You will build a sample threat model during
the workshops in the course by incorporating the principles of cybersafety
by design, information sharing, evidence capture, and incident response.
WHAT YOU WILL LEARNAt the end of this workshop, you will be able to:• Describe the terminology and definitions related to medical device
cybersecurity• Identify the requirements for cybersecurity by design, including
relevant standards, adversarial resilience analysis, remote access
control, supply chain rigor, and requirements for premarket
submissions in US and EU• Describe a proactive, risk-based approach in third-party collaboration,
integrating cybersecurity-specific postmarket requirements, and
working with researchers and organizations to identify emerging
vulnerabilities and threats• Describe best practices for evidence capture during safety investigations
that are independently reviewable, preserve information about the
event (including chain of custody and tamper resistance) while avoiding
privacy and surveillance concerns, and provide a mechanism for
reapplication of knowledge• Identify mechanisms for resilience and containment, including
minimizing exposures, creating secure environments for isolation and
segmentation and creating visible and safe modes of failure, while
preserving data integrity• Describe strategies for rapid, efficient cyber safety updates, such as
automation and process documentation, secure update processes,
stakeholder communication (including FDA), and OTS update verifications
Managing Medical Device Cybersecurity Risks
At a Glance
Dig deep into standards affecting cybersecurity, regulations, CVSS, and more .
Medical Device Data Integrity and 21 CFR Part 11 Training
WHO SHOULD ATTEND All QA/RA professionals and other cross-functional team members. All
attendees must have a basic familiarity with FDA 21 CFR Part 820.
WHAT YOU WILL LEARNAt the conclusion of this workshop, you will be able to:• Describe 21 CFR Part 11 requirements for electronic records and signatures• Understand why FDA places emphasis on computer system controls of
data integrity validation• Describe the regulatory requirements for QMS software systems• Understand and implement the requirements for electronic signatures• Identify Part 11 compliance “red flags” that FDA investigators look for
during an inspection• Understand the predicate rules contained in other FDA QSR subparts
and how they relate to electronic records• Understand what needs to be done to properly manage copies of records
and their backups, plus document retention rules• Understand why it’s best to apply critical thinking skills and a risk-based
approach to validation rather than focus on cost containment or audit
defense• Confidently assess the steps to protecting the integrity of your data and
limiting access to authorized individuals• Articulate the steps needed to implement a proper audit trail• Formulate the steps to create an internal culture around data integrity
Medical device RA/QA professionals focus so much on document creation
and data collection that they sometimes overlook the importance of proper
record maintenance and data integrity. This neglect often results in findings
during FDA inspections.
In this instructor-led class, we will guide you through all facets of compliance
with FDA 21 CFR Part 11 requirements governing electronic signatures and
records. You’ll see excerpts from several actual warning letters referencing
data integrity and review six common misconceptions that companies have
about Part 11 compliance. Moreover, you’ll learn about the linkages with
cybersecurity and validation in document and data management systems.
At a Glance
Learn all facets of compliance with FDA 21 CFR Part 11 requirements governing electronic signatures and records .
NEW ! NEW !
$2695 ■ Course Code: CRS ■ 1.6 CEUs
VIRTUAL INSTRUCTOR-LED ■ 4 HALF-DAYS
January 5–8February 15–18
March 29–April 1June 1–4
August 16–19September 27–30
Daily 1:00–5:00 PM Eastern time
$1395 ■ Course Code: DIS ■ 0.8 CEUs
VIRTUAL INSTRUCTOR-LED ■ 2 HALF-DAYS
January 18–19February 22–23
March 29–30May 3–4July 6–7
September 13–14Daily 1:00–5:00 PM Eastern time
1212For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events
OUR CLASSES ARE TAUGHT BY REGULATORY AND QUALITY PROFESSIONALS who average 20 years of real-world experience and all share a demonstrated
ability to teach effectively and keep the classroom lively and varied.
KATE LEITH
Kate is Sr . VP, Life Sciences Consulting 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.
Kate did a superb job of customizing the course both to our [organizational] context and to the diversity of our staff.
– Quality Engineer
ALICIA HEMPHILL
Alicia’s regulatory experience spans over two decades in negotiating and bringing medical devices from concept through to commercialization. She is responsible for multiple IDEs, PMAs, 510(k)s, direct FDA and NB Q-Sub negotiations, design dossiers, and multiple approvals in Canada, China, Japan, Latin America, and Australia .
Alicia was great at framing complex regulatory concepts in easy-to-understand terms.
– Director RA
YOGI DELLOW
Yogi has 20+ years of life sciences RA/QA and compliance experience, including medical device and pharmaceutical laws, regulations, and standards . She has served as Response Team Lead for FDA and Notified Body remediation activities regarding EU MDR, vigilance trends, Medwatch inquiries, FDA 483s, and recall reports. She has extensive experience working with manufacturers to understand the new EU MDR and IVDR .
Yogi is a dynamic instructor whose deep knowledge transfers impactfully to her students.
– RA Director
JOHN LOVE
John has over 20 years of training and course development experience that spans production management, quality and regulatory training, document control, root cause investigation, and internal auditing . John is passionate about developing and delivering training to ensure that learning objectives are met during classroom time and that lessons learned are maintained and applied back to the job.
John is effective and engaging — he sure knows how to work a classroom!
– Sr. Quality Director
RICHARD VINCINS
Richard 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 and has been involved in EC certification for over 60 tech files varying from Class I to III .
Richard’s ability to pull from his vast experience enhanced my training.
– VP Regulatory Affairs
CAROLYN TOMLINSON
Carolyn 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 .
Carolyn was fabulous – very knowledgeable and supported information with regulatory references and examples from the real world.
– Quality Manager
INSTRUCTOR SPOTLIGHT
For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events13
Courses may also be taught by other Oriel STAT A MATRIX regulatory and quality experts.
ED SIUREK
Ed 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 .
Ed’s a rock star. He brings a deep knowledge to the classroom, and made a dry topic interesting.
– Sr. Quality Director
GENE REDIG
Gene has over 25 years of medical device, biotech, and high-tech experience and is responsible for software, quality management systems, and regulatory projects and training . His expertise spans software development, quality systems, risk management, FDA/ISO regulations, qualification/validation, and auditing . This broad experience helps attendees get the most out of his training sessions .
Gene blew the class away with his in-depth knowledge of the subject.
– Director Software Engineering
PATRICE NAPODA
Patrice has over three decades of experience in regulatory submissions and approvals across the life sciences sector, with a special focus on the EU MDR/IVDR, regulatory remediation, and establishing and managing quality management systems . Students laud Patrice’s measured approach and ability to break down large concepts into understandable chunks.
Well worth the time – great course, great instructor!
– Clinical Affairs Manager
HARLOW THIELKE
Harlow brings over 20 years of experience to the classroom. From time spent as a college professor to conducting audits in the life sciences sector on a wide array of standards and regulations (including ISO 13485, ISO 9001, and 21 CFR 820) for major device manufacturers, Harlow brings passion, experience, and practical knowledge to each Oriel STAT A MATRIX training class .
Great instructor. He was able to answer all my questions and relate them back to my own organization!
– RA Manager
MARK PERKINS
Mark has two decades of medical device RA/QA experience in ISO 13485, 21 CFR 820 (FDA QSR), and EU requirements. His expertise spans consulting and training for CAPA, complaint handling, corrections and removals, and process validation, as well as auditing for compliance to ISO 13485, FDA QSR, and EU and Canadian requirements. Students appreciate Mark’s willingness to tailor the training to their individual needs and expectations .
Mark’s use of real-life experiences enhanced my learning. One of the best instructors I’ve ever had.
– CAPA Manager
OMAR GONZALES
Omar has over two decades of medical device and diagnostics RA/QA experience supporting life sciences companies across the globe, as well as serving as an auditor for SGS North America . Leveraging his Notified Body and industry expertise, Omar brings meaningful perspective and insight to each customer engagement . Clients consistently note his extensive knowledge and dedication to success as key distinctions .
Omar’s all-encompassing knowledge was amazing – he’s truly at the top of his game!
– VP Quality
INSTRUCTOR SPOTLIGHT
14For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events14
For Public, In-Person SeminarsRegistration fees are due and payable 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.
For Virtual Instructor-Led Training (VILT)Students will not be granted access to the link to access the virtual training classroom until full payment is received. The VILT session includes an eBook. Access to course materials is typically granted the Friday before the start of the class. Phone charges incurred if a participant uses a dial-in number to join the audio portion of the training are the responsibility of the student. VILT course participants are responsible to have the appropriate technology to join the training. This includes a computer with a web browser and a web camera with a microphone.
Payment and Purchase OrdersPersonal checks, company checks, Visa, American Express, MasterCard, and purchase orders are all accepted.
EXEMPLAR GLOBAL CERTIFIED COURSESOriel STAT A MATRIX is a registered training provider with Exemplar Global . Our Lead and Internal Auditor Training courses provide evidence of knowledge and skills aligned with their auditor personnel certification schemes. To successfully complete the course, you must earn a passing grade in the course assessments and pass the final examination. The exam is administered online for our virtual classes . To enroll in an Exemplar Global auditor personnel certification program, you will need to register with Exemplar Global and may need to complete additional requirements such providing an audit log. Full details of the Exemplar Global QMS Auditor personnel certification requirements and process may be found at www.exemplarglobal.org .
Students who pass the course requirements for our Remote Auditing class receive a certificate recognized by Exemplar Global as evidence of your competency as well as an Oriel STAT A MATRIX credential in assessing proficiency.
SubstitutionsIf 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 [email protected] and tell us the alternate’s name, the course name, and the session dates.
Transfers and CancellationsYou 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• 8–14 days before the course start date: 50% of the tuition• 7 or fewer days before the course start date: 100% of the tuition
Email your requests for cancellations, transfers, or substitutions to [email protected].
Hotel Information for In-Person TrainingAll courses are scheduled at hotels. Hotel locations are typically finalized 21–28 days prior to the start of the course and will be provided once the course is confirmed.
Session-Specific Links and Login Information for Virtual LearningLinks to and login information for the virtual classroom are provided by email, in most cases, the Friday before the start of the training.
NoticeOriel 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 canceled 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.
For quality assurance purposes, Oriel STAT A MATRIX may monitor or record our virtual and/or in-person seminars. Recordings will not be shared with learners. By attending the course, you agree to being recorded.
PolicyOriel STAT A MATRIX does not discriminate on the basis of race, national origin, religion, gender, age, or handicap in its policies, procedures, or practices.
Registration Fees Substitutions, Transfers, Cancellations Policy
800.472.6477 (US and Canada) 732.548.0600 (Select option 1)
PHONE TOLL-FREEcustomerservice@orielstat .com
EMAILwww.orielstat.com/training
ONLINE
REGISTRATION
For additional dates and locations or to register ■ www.orielstat.com 800.472.6477 ■ All courses can be delivered as private training events15