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2023 Audit Division Conference

November 2nd - 3rd, 2023

Advance Your Quality Expertise

October 3 – 5, 2022: Pre-Conference Workshops

The Audit Division is pleased to announce that it is offering tutorial courses preceding the conference. Discover workshop descriptions and more information below. Register for these courses through the main conference registration link

October 6 – 7, 2022: Conference Technical Program

Review the Technical Program Overview for a look into the conference.

Technical Program Overview

Technical Program Overview

Thursday, October 6, 2022

(all times listed are US Eastern Time)

7:00 a.m. Breakfast

8:00 a.m.  Welcome, Announcements, Keynote Introduction

8:30 a.m. Keynote Speaker: Ann Jordan, ASQ CEO

9:45 a.m. Track A - E Sessions
A1: Getting the 'So What' from 2nd party audits…And Doing it Remotely, Brian Wish
B1: Basic Auditing Principles with an Emphasis on Reporting, Murray Gonzalez
C1: Auditing in the World of Technological Advancement, Afaq Ahmed
D1: Writing Effective Opportunities for Improvement - Workshop, Denis Devos
E1: ISO19011: Time for a Revision? (Part 1 of 2), Denise Robitaille & Jennifer Admussen

10:30 a.m. Mid-morning Break (Snacks, Beverages, Exhibitors)

10:45 a.m. Track A - E Sessions
A2: Creating a Risk-based Audit Plan, Stephanie Gonzalez
B2: How to Audit Validation Sustainable Compliance in an Evolving & Technological Advanced Pharmaceutical Environment, Cathelene Compton
C2: Virtual vs On-site Audits, Dr. Ahmed Mubarak
D2: A Fresh Approach to Auditing - An overview of good contemporary auditing practices that add value, Elisabeth Thaller
E2: ISO19011: Time for a Revision? (Part 2 of 2), Denise Robitaille & Jennifer Admussen
Noon Lunch, Announcements, Keynote Speaker: Grace Duffy, Management & Performance Systems President
1:45 p.m.
Track A - E Sessions A3: Auditing Process Validations, Teresa Cherry B3: Wink, Hug and a Kiss - So Auditors & Auditees Can Embrace the Audit Process, Day Boswell C3: Using Technology to Manage a common ISO9001 Certificate, Colleen McGuigan D3: So, How will you Audit a Risk Assessment?, Angelo Scangas E3: Virtual Auditing Using Digital Tools, Karen Bolen
2:45 p.m. Track A - E Sessions A4: Risks and How to Mitigate the Effects of Uncontrolled Risks, Larry Litke B4: Auditing Processes for Effectiveness & Efficiency, Mark Durivage C4: Remote Audit Planning: ICT Tool Diagram, Shauna Wilson D4: Digital Transformation for Auditing, James Pan & Raymond Santos E4: The Future of Virtual Auditing and Conformity Assessment, Sheronda Jeffries
3:30 p.m. Afternoon Break (Snacks, Beverages, Exhibitors)
3:45 p.m. Track A - E Sessions A5: Regulatory Trends in Computer Systems Validation & Data Integrity, Gaurav Walia B5: Remote Audits and My Great Resignation, Nancy Pasquan C5: The Top 10 Most Common Supplier Auditing Mistakes & How to Avoid Them, Andrew Hendricks & Kellan Isle D5: Food Safety Virtual Audits - Tools and Tips, Tatiana Miranda E5: Digital Tool Emergence in an A/E Internal Audit Program, Teresa Hanson
6:30 p.m. Gala Reception Heavy hors d'oeuvres, carving station, beer and wine bar (6:30-7 p.m.) Raffle drawings, Sponsor Raffle prizes (7-7:30 p.m.) Music, Dancing, Refreshments (7:30-10 p.m.)

Friday, October 7, 2022

7:00 a.m. Breakfast

8:00 a.m.  Announcements, Final Raffle Drawing, Keynote Introduction

8:30 a.m. Keynote Speaker: Jim Leonard, Quality Support Group Sr. Consultant

9:45 a.m. Track A - E Sessions
F1: Data - Ten Questions Every Auditor Should Ask, Rai Chowdhary
G1: Virtual Auditing, Larry Litke
H1: How to Find Accredited Calibration Providers (Part 1 of 2), Heather Wade
I1: Quality 4.0 Psychology of Knowledge Management for Virtual Auditing, Milt Krivokuca
J1: Beyond Compliance - Managing your Compliance Obligations with ISO 37301, Elisabeth Thaller

10:30 a.m. Mid-morning Break (Snacks, Beverages, Exhibitors)

10:45 a.m. Track A - E Sessions
F2: ISO Auditing Practices Group – the Hidden Gem, Denise Robitaille
G2: Handling Audits as the Auditee, Teresa Cherry
H2: Beyond the Sticker and the Cert (Part 2 of 2), Heather Wade
J2: Internal Audits as an Enabler for Organizational Change, Denis Devos

Noon Lunch, Announcements, Keynote Speaker: Susan Gorveatte, Gorveatte Consulting Inc. President

1:45 p.m. Track A - E Sessions
F3: Dealing with Difficult Auditees, Rai Chowdary
G3: Ethics for the Auditor, Brian Wish
H3: Auditing over Multiple Time Zones, Iris Lavine
I3: How to Use Google Drive and other Platforms to Perform, Record and Share On-site or Virtual Medical Device Audits, Tracy Omdahl
J3: Integrating Quality and Risk Management Practices with New Product Introduction (NPI) Projects for small businesses, Gus Rathgeber

5:00 p.m. Audit Division Business Meeting

Pre-Conference Course cancellation Policy

Course Cancellation Policy

ASQ and the Audit Division reserve the right to cancel or re-schedule courses and to change instructors. Please be advised that in the event of a course cancellation, ASQ and the Audit Division is not responsible for airfare penalties or other travel related expenses you may incur.

If you need to cancel, we will refund your paid registration fee as noted below.

  • Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
  • Requests received within 5 business days of the course starting incur a $150 processing fee.
  • After the course starts, there are no refunds or transfers.
  • Registrants who fail to attend without advance notice are liable for the entire course fee.
  • If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.

You must successfully complete the entire course or program before IACET CEUs, if applicable, or ASQ Recertification Units and a Certificate of Completion can be awarded.

Managing Compliance – Implementing a Compliance Management System Based on ISO 37301 2 Day Course

Pre-Conference 2 Day Course

Managing Compliance – Implementing a Compliance Management System Based on ISO 37301

Every organization has compliance obligations that it must manage effectively to avoid or reduce the risk of business interruptions, penalties, damages to its reputation, and other undesired results. The more complex an organization, the higher will be its compliance-related risks. Compliance must not depend on one person or department but is to be seen as a company-wide effort based on solid values, integrity, and a compliance culture.

Since its publication in 2021, ISO 37301 has received much interest worldwide from organizations that are interested in the benefits of an effective compliance management system. Could ISO 37301 be the new ISO 9001?

Through this workshop students will gain a solid understanding of the requirements of ISO 37301 and how to implement a compliance management system in any type of organization.

In this workshop we will review the requirements of ‘ISO 37301:2021 Compliance Management Systems – Requirements with guidance for use’ in detail and discuss through interactive sessions how these requirements can be applied effectively in any type of organization. The participants will gain a solid understanding of the intent of the requirements of ISO 37301 and how they are inter-connected.

In a step-by-step approach and through a hands-on case study they will learn how to implement a compliance management system in an organization.


  • Demand of the new ISO 37301 – A contextual issue
  • Application and benefits of a compliance management system (CMS) based on ISO 37301
  • Terms and definitions related to compliance management systems
  • Values and good governance
  • Roles and responsibilities within a CMS
  • Elements of a CMS
  • Compliance related risks
  • How to determine a credible scope of a CMS
  • Compliance culture and the principles of compliance governance


Tuesday, Oct. 4 – Wednesday, Oct. 5, 2022

Instructor: Elisabeth Thaller
Level: Beginner
Price: $795

ISO 13485 Internal Workshop 2 Day Course

Pre-Conference 2 Day Course

ISO 13485 Internal Workshop

This “ISO 13485:2016 Internal Quality Systems Auditor” competency-based 2-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of effective internal audits in accordance with ISO 19011:2018, “Guidelines on Auditing Management Systems.” Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through internal audits that are required for a quality management system based on ISO 13485:2016. Our qualified instructors will also help you to boost your audit capabilities with the latest developments of the new 19011 standard. Students gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

Learning Objectives:

  • Describe the ISO 13485 Medical Device Quality Management System (QMS) – Requirements for Regulatory Purposes standard and development process
  • Identify medical device QMS terms
  • Describe the intent and requirements of ISO 13485:2016
  • Determine the evidence needed to demonstrate conformity to ISO 13485:2016
  • Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
  • Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
  • Apply the principles, processes, and methods of auditing
  • Demonstrate the activities involved in preparing for an audit
  • Determine an effective audit in the context of the auditee’s organizational situation
  • Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit
Course Outline:

This session includes a comprehensive review of ISO 13485:2016 and audit systems:

  • The Challenge for Top Management
  • Eight Quality Management Principles
  • The ISO Standard Explained
  • Family of Standards
  • Detailed read/review/explanation of ISO 13485:2016 Requirements

Exclusions - 

  • Overview of ISO 13485:2016 Requirements: Clause 4
  • Overview of ISO 13485:2016 Requirements: Clause 5
  • Overview of ISO 13485:2016 Requirements: Clause 6
  • Overview of ISO 13485:2016 Requirements: Clause 7
  • Overview of ISO 13485:2016 Requirements: Clause 8

Tuesday, Oct. 4 – Wednesday, Oct. 5, 2022

Instructor: Angelo Scangas
Level: All
Price: $795

Remote Auditing: The Good, the Bad and the Ugly 1 Day Course

Pre-Conference 1 Day Course

Remote Auditing: The Good, the Bad and the Ugly

It’s been more than two years since the auditing profession was catapulted into the “remote” arena. We blustered, stumbled, and thrashed our way up the steep learning curve striving to maintain the integrity of an essential QMS process.

This course will provide insight into great practices that have emerged, gaffs to be avoided and benefits to be derived. Through lecture and exercises, we’ll cover a variety of topics: application of risk-based thinking to the process, audit planning, technology issues, pitfalls to avoid, interview techniques to compensate for diminished environmental perception, scheduling, and many other useful tips. Participants will be encouraged to come ready to discuss challenges they’ve encountered and success stories they’ve experienced. The course has applicability to first, second, and third-party auditors.  Attendees will leave with a greater understanding of how to successfully transition a cornerstone of quality management from up close and personal to remote.

Wednesday, Oct. 5, 2022

Instructor: Denise Robitaille
Level: All
Price: $695

An Introduction to ISO 9001: Structure and Requirements 1 Day Course

Pre-Conference 1 Day Course

An Introduction to ISO 9001: Structure and Requirements

Many times each year, someone is hired and/or promoted into a Quality Management position and discovers the ISO 9001 requirements for the first time. The small 27-page standard is unfamiliar and oftentimes difficult to completely understand. The purpose of the tutorial is to introduce students to ISO 9001:2015 quality management system concepts in easy-to-understand words.

The tutorial is designed to provide a brief awareness of ISO 9001 system requirements, the process approach, risk-based thinking, and the quality management principles. Questions of clauses will be answered.

Bringing your own copy of the ISO 9001:2015 standard is the optimal situation; however, if you forget to bring your copy of the standard you can use the checklist provided in class as a substitute.

Job aids include:

  • ISO 9001:2015 Checklist with comments
  • Summary of the quality management principles.

Learning Outcomes:

Upon the completion of the tutorial, you will be able to:

  • Identify the quality management system concepts and relate them to your organization
  • Restate ISO 9001 system requirements in your own words
  • Define what the process approach means
  • Link the quality management principles to everyday activities

Wednesday, Oct. 5, 2022

Instructor: Paul Russell
Level: Beginner
Price: $695

Mitigating Risks in Remote Auditing 1 Day Course

Pre-Conference 1 Day Course

Mitigating Risks in Remote Auditing

It is the audit process and understanding the risks involved in collecting objective evidence that determines the validity of audit results. This applies to both remote and onsite audit methods. Both audit methods have pros and cons and risks that need to be mitigated to validate the audit results. During the pandemic, more companies including registrars moved to remote auditing as a method to maintain audit schedules. Without proper training and infrastructure, the validity of some remote audits is unknown; But data shows, remote auditing itself, when risks are mitigated, is a viable audit method.  

In this workshop, participants will work “hands on” assessing the remote auditing process using PFMEA to articulate potential failure modes, learn and apply the uses of technology in auditing, address communication issues, and define actions to improve your remote audit’s performance. Bring your collaborative program, mobile devices, drones, and laptops!

Tuesday, Oct. 4, 2022

Instructor: Shauna Wilson
Level: All

Assessing Human Factors of Digitalization 1 Day Course

Pre-Conference 1 Day Course

Assessing the Human Factors of Digitalization

The uncertainty and instability of today’s current business environments require agility to sustain process improvement. Technology continues to evolve and market changes are occurring at a rapid pace. Stagnation of thought must be avoided. A critical element to success in surviving this current situation is effectively understanding and utilizing the existing human capital. Understanding and developing human capital as these concepts apply in Quality 4.0 Digitization contributes to achieving organizational excellence.

  • Participation as a virtual or face-to-face team member or leader to accomplish a goal or objective.
  • Integration of human resource analytics to evaluate process performance.
  • Application of the interactions of technology and analytics with human factors within a process.
  • Identification of the potential obstacles to accomplishing the integration of the human and technical aspects of digitization in a process.

Classroom activities include evaluating these critical activities through discussion and quality tool exercises from the perspective of a quality auditor.

Wednesday, Oct. 5, 2022

Instructor: Milt Krivokuca
Level: All
Price: $695

Writing Effective Audit Reports 1 Day Course

Pre-Conference 1 Day Course

Writing Effective Audit Reports

This one-day course is for novice and experienced auditors who are looking to increase the effectiveness of their audit reports. Many organizations feel like their internal audits do not get the management visibility and attention that they deserve.  A more professional approach to internal audit reporting can help to improve this condition. A common shortcoming of many audit reports is that they are only a list of nonconformances and do not accurately reflect everything that was examined during the audit, leading the reader to wonder if all processes and requirements were examined. Participants will learn how to write effective non-conformance reports and Opportunities for Improvement and how to compile it all together into a comprehensive audit report that is easy to read and understand. This course is ideal for both new and experienced internal auditors. Every organization has compliance obligations that it must manage effectively.

Wednesday, Oct. 5, 2022

Instructor: Denis Devos
Level: All
Price: $695

Course Instructors

Course Instructors


Elisabeth Thaller


Elisabeth Thaller is President of Beyond Conformity Inc. with 25+ years of experience in management system consulting, training, auditing, and conformity assessments in multi-cultural environments worldwide.

Lead assessor for accreditation programs for safety and environmental management systems for the oil and gas industry. Certus-certified ISO 9001, ISO 14001 and ISO 45001 Lead Auditor.

Participated in the revision of ISO 19011:2018 (auditing management systems); member of US TAG 176, the ISO Auditing Practices Group, and the ISO Spanish Translation Task Force.

Co-Author of the book “Beyond Compliance” ISBN 987-1-932828-45-0

Elisabeth is fluent in German, English and Spanish.


Angelo Scangas


Angelo Scangas has more than 35 years of experience in engineering, quality systems, operations, and process improvement in the Medical Device, Automotive, Aerospace, Consumer, Electronic, Healthcare, and Chemical Industries. His background includes product development, design/process engineering, supply chain management, supplier quality, quality system design and regulatory compliance.

Angelo is a senior member of  American Society for Quality (ASQ), a CQA (ASQ Certified Quality Auditor), and a Lead Auditor for ISO 13485:2016, ISO 9001:2015, AS9100:2016 and IATF 16949:2016.

Denise Robitaille

Denise Robitaille


Denise Robitaille has authored over a dozen books, including The Corrective Action Handbook, and her most recent, Remote Auditing: A Quick and Simple Guide for Management System Auditors

She has participated internationally in standards development for over 20 years, serving in a variety of roles, including chair of PC302, (project committee that revised ISO 19011, guidance on auditing quality management systems). She is an ASQ Fellow and certified lead assessor. She’s conducted hundreds of trainings on multiple topics including corrective action, root cause analysis and internal auditing. Denise is internationally recognized for her work and is a frequent speaker at conferences.


Paul Russell


Paul Russell, CQA, is Managing Director for QualityWBT Center for Education and the JP Russell Learning Center. For 18 years, Paul Russell (ASQ Certified Quality Auditor) has worked with Web-based training and blended learning classes approved by the American Society for Quality. He is a voting member of the United States Technical Advisory Group (US TAG) ISO/TC 176 for Quality Management Systems standards. Paul has put “boots on the ground” performing over 100 internal audits in the health industry to maintain Food and Drug Administration (FDA) and European Union (EU) compliance for over 45 blood bank locations, five blood manufacturing facilities, and over 31 blood mobiles. Paul has performed over 160 pharmacy audits in the Midwest/Northeast/Mid-Atlantic/South regions of the US to maintain Drug Enforcement Agency (DEA) and FDA compliance as well as pharmacy specific adherence to the drug laws of 21 states and one District. He has taught face-to-face internal training classes regarding current Good Manufacturing Practices (GMP) to support Corrective Action (CA) and various audit conformance measures. Paul has taught many face-to-face multiple-day classes regarding the ISO 9001 Internal Auditor, ISO 9001 Lead Auditor, and ISO 13485 Lead Auditor.

Paul has spent many fun years with ISO 9001, ISO 13485, 21 CFR 606, 21 CFR 640, 21 CFR 860, and 21 CFR 1300-1317.


Shauna Wilson


Shauna Wilson’s research and experience in virtual team communication and development of virtual auditing methods has made her the leading expert in Remote Auditing. She earned an MS in Engineering focused on Organizational Performance Technologies and Instructional Design. Shauna wrote Tools to Create High Performance Remote Teams and co-authored eAuditing Fundamentals: Virtual Communication and Remote Auditing. Shauna has been featured in Quality Progress, The Auditor, and ASTD’s InfoLine.  Shauna served as the US Expert for PC/TAG302 ISO19011:2018 Auditing Management Systems Guideline and holds an Exemplar’s Principal QMS Auditor certification. Shauna is currently serving as ASQ Portland Section Chair.


Dr. Milton Krivokuca


Dr. Milton Krivokuca is the Interim Program Coordinator for the Master of Science Quality Assurance program at California State University Dominguez Hills, Carson, CA. He has presented contemporary quality topics at conferences in Europe, Middle East, Africa, and Asia, as well as locations throughout the United States and Canada. He is past chair of ASQ, Quality Management Division, an ASQ Fellow, ASQ Los Angeles Section 700 Simon Collier Quality Award recipient and 2020 ASQ Section 701 Orange Empire Quality Guru of the Year.

Dr. Krivokuca’s advanced degrees include an MA, MBA, and a DBA. He is a CMQ/OE and CQA.

Denis Devos

Denis Devos


Denis Devos is a professional engineer with a long career providing QMS training and advisory services. He is a Fellow of ASQ and is a recognized expert in the application of the ISO 9001, IATF 16949 and ISO 14001 Standards. Denis was the developer of the Risk is the Compass risk-based audit model in 2001. He works with clients in a variety of industries, providing internal audit services and training for QA practitioners and internal auditors. Denis is a regular contributor to the Audit Division conference, having shared his insights and expertise with us for over 15 years in a row.  He also contributed to the recently published ASQ Certified Quality Auditor Handbook, Fifth Edition.