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Keynote Speaker Information
Rai Chowdhary AI and Quality Audits - A Reality Check
AI holds great promise for the quality profession. It will become extremely valuable as models get refined, and more information becomes available. Rai has been experimenting and discovering the bright (and not so bright) side of using AI. He will share several of his key experiences using AI in audits, and a few from AI applications to quality at large. Along the way he has developed key approaches to validate AI responses, and methods to spot and steer around inaccurate information.
Rai is a relentless learner who continues to expand his portfolio of knowledge, skills, and abilities. He brings over 40 years of diverse experience across automotive, aerospace, life sciences, food products, and service industries. His undergraduate studies included Mechanical and Production Engineering, with graduate study in Materials Science. He holds several ASQ Certifications: CSQP, Six Sigma Black Belt, CQE, and CMQ/OE. Rai is also a Lead Auditor for ISO 9001, 13485, and 27001.
He has led / participated / witnessed hundreds of audits starting 1995 covering a broad range of industries and regulations; he serves on standards development committees (ISO TC 176, among others). Rai was recognized as “Expert on WG 28 for the development of ISO/TS 10020:2022” (Organizational Change Management).
Lisa El-Shall Ensuring Consumer Safety through Robust Auditing Practices
In an era where regulatory landscapes are continuously evolving and uncertainty prevails; the role of auditors has never been more crucial. Auditors serve a critical function as the first line of defense or protection for consumers, especially amidst the recent developments at the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). This keynote will highlight the integral role auditors play in maintaining the integrity and safety of consumer products. Their vigilance ensures that companies adhere to regulatory standards and best practices, thereby safeguarding public health. This session will provide several recent examples from the food, drug and cosmetics industries to illustrate the pivotal role auditors can play in raising awareness of risks and potentially avoiding recalls and enforcement actions.
Denis Devos Everything I Know about Lean I Learned from My Grandmother
It's no surprise that many Lean concepts are rooted in common-sense and simplicity. I've recently realized that my wise old grandmother taught me a lot of the key tenets of Lean when I was just a child. In this tribute to grandmother's everywhere, we will acknowledge their crucial role in teaching us to work hard, be organized, not be wasteful, and face our problems head on.
Pre-Conference Tutorials
Rai Chowdhary
What Auditors Miss in an AI and Data Driven World: 25 Things to Check
Full Day Course: Sept. 9, 2025
8:00 am - 5:00 pm
$599.00
Course Description:
Just about all QMS standards - ISO 9001, 13485, IATF 16949, AS 9100D, TL 9000 and many regulations such as FDA 21 CFR 820, EUMDR, and USDA, leaning towards the use of evidence to support conformance or compliance. Additionally, reliance on data and statistical methods is also emphasized. Today’s data driven world is also increasingly permeated with AI.
As it is - the pace of data generation is astounding, and it is only going to accelerate. According to one source*, the amount of data created, captured, copied, and consumed worldwide from 2010 to 2025 is estimated to increase by 90X. Are today’s and future auditors prepared for such upheaval?
Join us for a unique, timely, and engaging event as Rai shares his know-how on 25 things every auditor should look for when examining evidence, data, its analysis, and the use of AI by firms. Here are the key takeaways:
- The chain from events, evidence, and situations to data, its analysis, reporting, presentation interpretation – and errors in the same. Understand how error propagation can severely compromise analyses and information.
- Practice with numerous audit case studies and develop / create the right questions to ask in each case.
- In class practice on (using Excel on your laptop) data set provided by Rai and develop the ability to spot the right areas / process steps where audits will be most effective.
- Understand key points from the above standards that are applicable to data, analytics, and how to check for potential nonconformances when AI is used.
- Learn 25 things you can do to boost immunity against flawed evidence data errors at your organization.
Rai is a relentless learner who continues to expand his portfolio of knowledge, skills, and abilities. He brings over 40 years of diverse experience across automotive, aerospace, life sciences, food products, and service industries. His undergraduate studies included Mechanical and Production Engineering, with graduate study in Materials Science. He holds several ASQ Certifications: CSQP, Six Sigma Black Belt, CQE, and CMQ/OE. Rai is also a Lead Auditor for ISO 9001, 13485, and 27001.
He has led / participated / witnessed hundreds of audits starting 1995 covering a broad range of industries and regulations; he serves on standards development committees (ISO TC 176, among others). Rai was recognized as “Expert on WG 28 for the development of ISO/TS 10020:2022” (Organizational Change Management).
Denis Devos
Risk is the Compass - A Process Approach Auditing Model Using Risks and Controls
Full Day Course: Sept. 9, 2025
8:00 am - 5:00 pm
$599.00
Course Description:
We are pleased to offer this one-day tutorial to professional third-party auditors and internal auditors alike. Texts and training sessions always talk about considering risks during an audit, but stop short of offering a template to assist in audit planning and preparation. Our session will introduce auditors to an auditing approach which includes process risks along with their corresponding enablers, or process controls. Topics will include the potential impact of AI in the preparation and conducting of audits. Many auditors find themselves unable to perform a QMS audit beyond written procedures and checklists. Hands-on workshops will teach simple techniques to help auditors see that Risk is the Compass for charting their course through a challenging audit.
Instructor Bio:
Denis Devos is a professional engineer with a long career providing QMS training and advisory services. He is a Fellow of the ASQ, the current Chair of the ASQ Quality Management Division 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 published ASQ Certified Quality Auditor Handbook, Fifth Edition.
Cathleen Howick
FSPCA IA Conducting Vulnerability Assessments Participant Course
Full Day Course: Sept. 9, 2025
8:00 am - 5:00 pm
$599.00
Course Description: This course will provide participants with the knowledge to implement the requirements of conducting a vulnerability assessment under the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) regulation of the U.S. Food and Drug Administration (FDA). This regulation is one of a number of regulations and guidance that implement the provisions of the 2011 Food Safety Modernization Act (FSMA).
The Mitigation Strategies to Protect Food Against Intentional Adulteration regulation (referred to as the IA rule) is aimed at preventing intentional adulteration from acts intended to cause wide-scale public health harm, including acts of terrorism targeting the food supply. The regulation requires that certain activities must be completed by a “food defense qualified individual” who has successfully completed training in the conduct of a vulnerability assessment (21 CFR 121.4). This course developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet the requirements for a “food defense qualified individual” responsible for conducting a vulnerability assessment.
The IA rule does not specify a particular method that you must use to conduct your vulnerability assessment. Two potential methods that can be used are the Key Activity Type (KAT) and/or the Three Fundamental Elements methods. If you conduct your vulnerability assessment using the KAT method with no modifications, you should consider completing the FSPCA IA Conducting Vulnerability Assessments Using Key Activity Types course and may not need the training provided in this course. However, if you use any modifications to the KAT method or plan to use the Three Fundamental Elements method, then this course would provide valuable insights.
Upon successful completion, you will receive an official FSPCA Food Defense "Qualified Individual" certificate issued by IFPTI, $60 addtl’ fee.
Requirements:
- Participants must have access to the FSPCA IAVA Participant Manual and Exercise Workbook. Hardcopies of FSPCA Participants manuals are available for purchase through the FSPCA Bookstore (https://bookstorefspca.ifpti.org/index.php/iava.html) or on Amazon.com (https://a.co/d/1HUgU9J).
- As this course covers the portion of the Rule specific to conducting vulnerability assessments, participants should have a basic understanding of the IA rule. Strongly recommend attending the free FSPCA Overview of the IA Rule Course https://www.fspca.net/ia-rule.
- Strongly recommend bringing a computer/tablet/device to work on the exercises required to complete this course.
Instructor Bio: Cathleen Howick, MS. FSPCA PCQI 2.0, FSVP & IAVA L.I.
She has over 30 years of experience in the dietary supplement industry. Her work has included almost all aspects of quality control and quality assurance, including microbiology, quality engineering, site compliance lead, and corporate auditor. She has a BS in Biology from Loyola Marymount University and a Master’s in Regulatory Science with an emphasis in Food Safety from Arizona State University. Cathleen is a Certified Quality Auditor and Certified HACCP Auditor. She is also an FSPCA lead instructor for Preventive Controls for Human Food, Foreign Supplier Verification Programs, and Intentional Adulteration Vulnerability Assessments.
Jim Shore
GxP for Supplier and Internal Audits
Full Day Course: Sept. 9, 2025
8:00 am - 5:00 pm
$599.00
Course Description: Looking to sharpen your auditing skills or earn points toward recertification? Whether you're new to auditing or simply need a refresher, this dynamic one-day course is designed for professionals who want to enhance their effectiveness in both supplier and internal audits.
Led by an expert with over 30 years of industry experience, this class offers practical insights and proven techniques to conduct efficient, impactful audits that meet GxP standards. You'll learn how to apply the principles of auditing to both internal operations and external suppliers, gaining tools and strategies you can use immediately in your role.
Don’t miss this opportunity to level up your auditing expertise in just one day!
Agenda Overview
- Session 1: Introduction to Internal and Supplier Auditing
- Session 2: Key Components of Internal and Supplier Audits
- Session 3: The Audit Process
- Session 4: Common Findings and Issues
- Session 5: Effective Internal and Supplier Relationship Management
- Session 6: Best Practices and Industry Standards
- Session 7: Conclusion and Wrap-Up
James “Gunny” Shore is the chief quality officer at Quality Lean Solutions. He offers over 30 years of quality and supplier management experience working in medical devices, semiconductors, aerospace, and defense (Titan Medical, Lake Region, Nypro Healthcare, Boston Scientific, Aspect Medical, ACMI, Brooks Automation, and Raytheon). Quality Lean Solutions provides Simple Sustainable Solutions™ to companies in the medical device and high-tech industries by providing value-added auditing services, lean manufacturing, development of quality management systems, assisting with the EU Medical Device Regulation transitions, and performing inspections to the American Association of Tissue Banks standard. Shore’s professional certifications include ASQ Certified Six Sigma Black Belt, ASQ Certified Quality Manager/Operations Excellence, Certified Quality Auditor, and Certified Mechanical Inspector, as well as ASQ Senior Member. He is a Certified Welding Inspector and Test Supervisor for the American Welding Society. Co-author of the book entitled “Proactive Supplier Quality Management in the Medical Device Industry,” which is published by Quality Press. (100% of the royalties are donated to Veteran service organizations.) Shore served his country in the United States Marine Corps for 15 years as a Helicopter Crew Chief/door Gunner and was Honorably Discharged at the rank of Gunnery Sergeant (E-7).
Angelo Scangas
Risk Management/FMEA Auditing - Best Practices
Half Day Course: Sept. 9, 2025
8:00 am - 12:00 pm
$299.00
Course Description:
Auditors continue to struggle with effective and efficient audit execution of Risk Assessments/FMEAs. Common deficiencies include an over-reliance on checklists and inadequate understanding of the documentation risk assessments, including linkage of audit procedures to the risks they are designed to address. So what exactly does that mean? In plain English, this means the auditor needs to:
- Understand where, within the company’s quality/business system are the highest product/process risks.
- Tailor his or her audit program to evaluate risk management effectiveness.
- Understand the purpose and structure of FMEAs (or other risk assessment tools)
- Know how to audit the Severity, Occurrence and Detectability criteria
- Evaluate the effectiveness of the mitigations to reduce risk
- Audit for value
Expected Takeaways
You'll learn to:
- Determine the right time to audit Risk Assessments
- Identify the critical requirements for the product or process to be included in a risk assessment
- Identify and classify potential failure modes
- Evaluate potential failure mode severity
- Evaluate potential causes to the failures
Angelo Scangas is President of Quality Support Group, Inc., an International Consulting and Training organization. Angelo has a B.S. in Chemical Engineering, M.S. in Manufacturing Engineering and a MBA. Angelo is a senior member of the American Society for Quality and a long-time member leader of the ASQ Audit Division (Webinar Chair).
Angelo has more than 30 years of experience in the Medical Device, Consumer, Electronic, Healthcare and Chemical Industries working in product development, manufacturing, quality assurance and process improvement.
Heather Wade
The 3Rs of Calibration; Reading, Writing, and Reviewing Accreditation Scopes, Service Requests and Calibration Certificates
Half Day Course: Sept. 9, 2025
1:00 pm - 5:00 pm
$299.00
Course Description:
Personnel who must manage measurement & test equipment can feel overwhelmed knowing how to find appropriate calibration vendors, what to ask for when seeking measurement & test equipment calibration, and then how to read the calibration certificate. Often, this frustration arises because they were never trained how to do these activities.This session is appropriate for consumers and suppliers of calibration services. This tutorial will include hands-on exercises for attendees to practice searching for and interpreting ISO/IEC 17025 calibration scopes of accreditation, comparing and interpreting scopes of accreditation, and reviewing and interpreting calibration certificates to meet their requirements. Please bring your laptops and any examples of calibration certificates with which you'd like to practice. Examples will also be provided for hands-on activities. Learning Objectives: At the end of this 4-hour tutorial, participants will know: 1) How to search for appropriate calibration vendors and understanding scopes of accreditation, 2. What to communicate to calibration vendors so you get what you need the first time, 3) To read and interpret calibration certificates and use the data to reduce your risks and ensure better measurements.
Instructor Bio:
Heather is an internationally recognized metrology subject matter expert & a popular presenter. She is ASQ-Measurement Quality Division’s Immediate Past Chair and an A2LA ISO/IEC 17025 Lead and Technical Assessor for testing and calibration labs. She is an active member of several international metrology organizations and is Editor and co-author of ASQ’s Metrology Handbook, 3rd Edition.
A graduate of University of Michigan with a B.S. in Biology, Heather has worked as a microbiologist, physical test engineer, and chemist before moving full-time into metrology. With her nearly 30 years professional experience, she provides “Pain Relief for Measurement Headaches” for her consulting clients.