2016 Conference Schedule

 
TRACK Track 1 Track 2 Track 3 Track 4
ROOM Salon D Gallery Hanover Salon C
MODERATOR Mel Downes

Director, Fire Control Systems & Technology
Weapons & Software Engineering Center (WSEC)
Bob Spinosa

QA Director, Multi Packaging Solutions
Carl Perini

Global Corporate Quality, Ashland Specialty Ingredients
Long P. Nguyen

Competency Dean, Reliability Engineering Chief, Reliability Management Office Quality Engineering & System Assurance Directorate
7:20 - 8:20 am REGISTRATION, CONTINENTAL BREAKFAST, NETWORKING
8:20 - 9:20 am Keynote Speaker:  Kirsten Smith 
Made to Thrive Consulting LLC

"The Human Side of Auditing"
Session A

9:30 - 10:30 am
 Paul Ranky Ph.D. 
Tenured Professor of Engineering
Design, Manufacturing, Industrial and Management Systems at NJIT (New Jersey Institute of Technology)  

Quality Design Review Methods, Tools, and Case Studies
Jay Patel 
CEO of Quality & Productivity Solutions 

Risk Based Thinking and Risk Management in ISO 9001:2015
Ray Lotfi   

Chair of Mid Atlantic Pharmaceutical Bio Medical (MAPBDG) 

Dynamic FEMEA
Douglas Ray, PStat, CRE, SSBB  
Melissa Jablonski 
Christopher Drake

Design and Analysis of Experiments Planning and Execution: An Interactive Workshop
10:30 - 11:00 am

BREAK - NETWORKING - EXHIBITS

Session B

11:00 - 12:00 noon
Jeff Lee  
Jeff Lee Consulting 

Process Improvement: The Greatest Thing That Nobody Wants
Tri Nguyen 
Hubbel Power Systems

 
Why organizations fail to produce sustained results through Lean Six Sigma?
Jeff Boatman,  
Senior SME, Quality Systems and
QPharma, Inc.

FDA’s PRODUCT TRACEABILITY INITIATIVES: UDI and SNI
Douglas Ray, PStat, CRE, SSBB Melissa Jablonski 
Christopher Drake 

Design and Analysis of Experiments Planning and Execution: An Interactive Workshop
12:00 - 1:45 pm

Lunch - Networking - Exhibits

Session C

1:45 - 2:45 pm
Christian Britt 
Principal of EOI (Engineering and Operational Improvements) Consulting Group

Cost of Quality- Obtaining Resources in the Resolution of Quality Issues
Bob Norris
Magic Hat Consulting (MHC)

Demystifying Organizational
Change Management: Bringing
Tangibility to Transformation
Ann Meeker-O'Connell
Head, Risk Management and External Engagement  for Johnson & Johnson’s Bioresearch Quality and Compliance  
 
An innovative, streamlined quality model focused on preventing “Errors that matter.”
Nicholas Ruffini   
Thorsten Roberts

Reliability Modeling and Design for Reliability best practices
2:45 – 3:00 pm

BREAK - NETWORKING - EXHIBITS

Session D

3:00 – 4:00 pm
James August
Quality Assurance Manager CCL Label  

Global 8D, the master Corrective Action process”
 Rod Colon
Executive Coach and Author  

"When friends learn" A bold new approach to finding jobs, clients, and business opportunities
Bob Seltzer 
President and Principal Consultant for Worldwide GMP Compliance Professional 

Readying for the CPGP Exam w/ the Right References
Richard Eng 
Associate Department Head of Applied Software Engineering at the MITRE Corporation

Applying Machine Learning Techniques to Improve Quality 
4:00 – 4:30 pm NETWORKING

Management reserves the right to make cancellations and changes without notice.



2013 Conference Schedule:
TRACK Track 1
Customer Satisfaction
Track 2
Problem Solving
Track 3
FDA Regulated
Track 4
Quality Approaches
ROOM Salon D Gallery Hanover Salon C
MODERATOR Mel Downes

Chief, Weapons, FC and SW Quality, Reliability and Safety Engineering QE&SA Dir
Bob Spinosa

QA Director, Multi Packaging Solutions
Carl Perini

Corporate Quality,International Specialty Ingredients
Timothy Grealy

Acting Div Chief, Process Improvement & Transformation Support Division
Business Transformation & E-Systems Directorate
7:20 - 8:20 am REGISTRATION, CONTINENTAL BREAKFAST, NETWORKING
8:20 - 9:20 am Keynote Speaker: Brigadier General John J. McGuiness
Senior Commander,
Program Executive Officer Ammunition and Senior Commander Picatinny Arsenal
Session A

9:30 - 10:30 am
Leadership Insanity

Wally Hauck, Ph.D

Organizational Consultant at Optimum Leadership
Mind Bending Innovation

Andréa Stevens
Manager of Innovation/Idea Catalyst, ARDEC,
Ralph Tillinghast & Dr. Andrei Cernasov
Associate for Innovation, ARDEC
Medical Device Single Audit Program (MDSAP)

Robert Ruff
FDA Compliance Officer
A Simulation-Based Comparison of Taguchi OA and Response-Surface Methods in the Context of the New SOP for DOE

Douglas Ray,
Thorsten Roberts
10:30 - 11:00 am

BREAK - NETWORKING - EXHIBITS

Session B

11:00 - 12:00 noon

Breakthrough Management

Brian Swayne MBA, MBB

Executive Vice President of Business Development with Juran Institute.

Mind Bending Innovation

Andréa Stevens
Manager of Innovation/Idea Catalyst, ARDEC,
Ralph Tillinghast & Dr. Andrei Cernasov
Associate for Innovation, ARDEC
Risk Management

Tim Lozier & Tom Barlow
EtQ Inc
Lean Six Sigma Success Stories


Ed May,

ASQ CSSBB, CMQ/OE, CQE, CQA
Quality Consultant, Adjunct Professor, and On-site instructor
12:00 - 1:45 pm

Lunch with guest speaker (Tentative) from United States Military Academy West Point - Networking - Exhibitors

Session C

1:45 - 2:45 pm
How to Implement Enterprise Wide Quality Programs

 Daniel Bharadwaj
Vice President of Quality at Billtrust
Mind Bending Innovation

Andréa Stevens
Manager of Innovation/Idea Catalyst, ARDEC,
Ralph Tillinghast & Dr. Andrei Cernasov
Associate for Innovation, ARDEC
How the Body Quality Controls Functions Stimulate your QC Imagination

Judith Fitzpatric Ph.D

Bergen Community College
Logit Analysis and Design of Sensitivity Experiments: Armament Engineering Case-Study Introduction to Best-Practices

Douglas Ray, Eli Golden
2:45 – 3:00 pm

BREAK - NETWORKING - EXHIBITS

Session D

3:00 – 4:00 pm
An overview of the Baldrige Criteria for Performance Excellence

Kathleen Burke PhD, RN
Assistant Dean in Charge of Nursing Programs,
Ramapo College of New Jersey
Integrating Baldrige and Other Performance Improvement Models

Brad Sampson & Jim Caiazzo
The FDA’s Strategic Initiative - Focus on Quality versus Compliance

Vinny Sastri, Ph.D.

President, WINOVIA LLC
 Interesting Life of an Auditor

Joel Schwartzman MBA

Retired FDA Inspector, Method Development Chemist, Quality Engineering Manager, QA Director and ISO 9000 Auditor
4:00 – 4:30 pm NETWORKING

 




2012 Conference Schedule:
TRACK Track 1
Customer Satisfaction
Track 2
Problem Solving
Track 3
FDA Regulated
Track 4
Quality Approaches
ROOM Salon D Gallery Hanover Salon C
MODERATOR John Finno
Associate Director for Integration, US ARMY
Bob Spinosa
QA Director, Multipacking Solution
Carl Perini
Corporate Quality,International Specialty Products
Timothy Grealy
Process Advocate, US ARMY
7:20 - 8:20 am REGISTRATION, CONTINENTAL BREAKFAST, NETWORKING
8:20 - 9:20 am Keynote Speaker: Shin Taguchi
President ASI Consulting Group LLC; Son of the legendary Genichi Taguchi.
Consultant to General Motors, Hyundai Motors, Ford Motor Co, Kodak, Texas instruments, and Lexmark.
He has trained over 25,000 engineers worldwide in quality engineering, product and process optimization, and his fathers renowned Taguchi Methods.
Session A

9:30 - 10:30 am
Eileen Rubin
BAE Systems Senior Principal Engineer in Performance Excellence

"A Non-Traditional Approach to Product/Process QA"
Denise Robitaillie
Author and Internationally Recognized Speaker

 "ISO 9004: The Path to Experiencing Sustained Value from Management Review" Part 1
Rob Ruff
FDA Compliance Officer

"Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program"
Don Day
Co-founder of Tec-Ease & President and Chief Engineer of Inter-Mec Systems Manufacturing, Inc.

"Enable New Technology with GD&T!"
10:30 - 11:00 am

BREAK - NETWORKING - EXHIBITS

Session B

11:00 - 12:00 noon
Bob Fantina & Baboo Kureemun
Consultant

Workshop: "Your Customers’ Perception of Quality: What it Means to Your Bottom Line and How to Control it "
Denise Robitaillie
Author and Internationally Recognized Speaker

 "ISO 9004: The Path to Experiencing Sustained Value from Management Review" Part 2
Steve Obolewicz
QMI-SAI Global Trainer

"Risk Management for Medical Device Industry: WHY, WHAT, and HOW."
Nicole Radziwill
Assistant Professor Department - Integrated Science & Technology, James Madison University

"Agile Software Development and the Learning Organization."
12:00 - 1:45 pm

LUNCH

Session C

1:45 - 2:45 pm
Bob Fantina & Baboo Kureemun
Consultant

Workshop: "Your Customers’ Perception of Quality: What it Means to Your Bottom Line and How to Control it"
Vic Nanda
President of AQIA & Author

"Framework for Overcoming Resistance & Accelerating Change"
Bob Seltzer
Reg. Compliance Manager at GlaxoSmithKline Consumer Healthcare

 "Maintaining One’s Literacy in Pharmaceutical GMPs"
Jim Bowie
Author and Strategic Performance Improvement Expert

"Excerpts from (Lean Acres) Strategic Innovation and Improvement"
2:45 – 3:00 pm

BREAK - NETWORKING - EXHIBITS

Session D

3:00 – 4:00 pm

Jim August
Director of Quality American Bilrite

"Leadership by the Cliché"

Jack Frost
President firm Foundations LLC

"Sustainability as a Core Strategy - It's Not Just About Being Green"
Dr. Irwin B. Silverstein
Vice President and Chief Operating Officer IPEA Pharmaceutical

"GMP Supplier Qualification and Supply Chain Security"
Mike Parrillo
Certification Training Instructor & Long standing volunteer on behalf of ASQ

"Measurement System Analysis (MSA) From Basic Concepts to Practical Application."
4:00 – 4:30 pm NETWORKING


2011 Conference Schedule:
TRACK Track 1
Reliability & Customer Satisfaction (for: Innovation, Suppliers, Partners, Alignment to Goals)
Track 2
Strengthening Problem Solving Networks (Teamwork, Leadership, Workforce Engagement)
Track 3
FDA Regulated (Pharmaceutical, Lessons Learned)
Track 4
What’s New
ROOM Salon D Gallery Hanover Salon C
MODERATOR John Finno
Associate Director for Integration, US ARMY
Bob Spinosa
QA Director, Multipacking Solution
Carl Perini
Corporate Quality,International Specialty Products
Timothy Grealy
Process Advocate, US ARMY
7:20 - 8:20 am REGISTRATION, CONTINENTAL BREAKFAST, NETWORKING
8:20 - 9:20 am

KEYNOTE SPEAKER: Forrest Breyfogle III Lean Six Sigma: Going Beyond the Project President and CEO, Smarter Solutions, Inc. Professional Engineer & ASQ Fellow, Received 2004 Crosby Medal for book, Implementing Six Sigma, author or co-author of 13 Books

Session A

9:30 - 10:30 am
Rosario Lo Cascio,
Christel Seitel, and Alicia Correa
ARDEC

Improve quality by increasing customer satisfaction and shareholders’ value
Linda Bankoski
President, Quality Leadership Associates

Key to Practical Business Improvement
Russ Nichols
Quality Manager SGS

HACCP Overview
Dorothy Bowers
Retired from Merck & Co., Inc. where she was a Vice President,

Environment Quality, Social Responsibility - Finding the Sweet Spot
10:30 - 10:45pm

BREAKS

Session B

10:45 - 11:45 am
Long Nguyen
ARDEC

Developing Design for Reliability Procedures, Processes, and Training

Stanley Cherkasky
Managing Partner & Founder of Change Management Consulting

Building Quality Relationships Part 1
Jeff Boatman
QPharma Inc.

FDA Guidance:Quality Systems for Pharmaceutical Manufacturers
Timothy R. Foran
Retired from Raytheon SAS

Small Disadvantaged Business Partnering Success
11:45 - 1:30 pm

LUNCH

Session C

1:30 - 2:30 pm
Dr. Lev Klyatis Sr.
Consultant SoHaR Inc.

Reliability Testing and Necessary Equipment
Stan Cherkasky
Managing Partner & Founder of Change Management Consulting

Building Quality Relationships Part 2
Robert Maffei
Compliance Officer FDA

Lessons Learned in FDA Compliance
Vivian Hollifield Ph.D.
Student, Department of Political Science, West Virginia University

Government Provided Data Chaos
2:30 – 3:00 pm

BREAKS

Session D

3:00 – 4:00 pm
David Verbitsky PhD

Profitable Reliability Assurance Using Early Failure Analysis
Ronald Williams
President, Optimum Business Concepts

Root Cause Analysis
DEBORAH BONJIONE
VP of HR,
Change Management Consulting, Inc.,

TEAM BUILDING AND LEADERSHIP DEVELOPMENT
Jamil Hassounah Sr.
Director, Quality Assurance with SMSC

A Quality Management Model for Small Organizations
4:00 – 4:30 pm NETWORKING



2010 Conference Schedule:
TIME TRACK ONE - Practical Applications: Statistics, R&R, DOE, Software TRACK TWO - Leadership TRACK THREE - FDA Regulated TRACK FOUR - Best Practices: Green Quality, Software Quality, Logistics Quality
ROOM Salon D Gallery Hanover Salon C
MODERATOR Bob Spinosa
QA Director, Multipacking Solution
John Finno
Associate Director for Integration, US ARMY
Carl Perini
Corporate Quality, International Specialty Products
Marc Saperstein
Strategic Quality Initiatives, US ARMY
7:20 - 8:20 am REGISTRATION, CONTINENTAL BREAKFAST, NETWORKING
8:20 - 9:20 am

KEYNOTE SPEAKER: Mr. Donald Wheeler
Consulting Statistician, Author, world renowned Statistical Process Control Expert "Two Routes to Process Improvement"

Session A

9:30 - 10:30 am
Walter McGee
FIAE

Raytheon Space and Airborne

"Out of the Crisis - The Addendum"
Jim August

Director of Quality
American Biltrite Inc.

"Finding Best Practices, Mining the Baldrige Criteria".
Irwin Silverstein

Vice President and Chief Operating Officer Auditing

“Assuring Drug Safety through Supply Chain Security”
Jaxon Teck

ARDEC's RoosterLOG™

"Early voice of logistics quality"™
10:30 - 10:45pm

COFFEE BREAK / NETWORKING / EXHIBITS

Session B

10:45 - 11:45 am
Louis A. Johnson

Senior Technical
Training Specialist and Mentor with Minitab, Inc.

"Robust Design Presentation"
James J. Caiazzo
Vince Matrisciano

ARDEC

"Initiatives in Leadership Development".
Priti Desai

Hoffman-La Roche 6 Sigma Black Belt

"Design For Six Sigma: Developing A Right First Time Tool For Annual Product Review "
Aimee Siegler

"Environmental Concerns in the Supply Chain".

"RoHS, WEEE, China RoHS, REACH, SR"
11:45 - 1:30 pm

LUNCH / EXHIBITS / NETWORKING

Session C

1:30 - 2:30 pm
Jim Colton

Senior Technical Training Specialist and Mentor with Minitab, Inc.


"Common Reasons Designed Experiments Fail"
Burton S. Liebesman

 Sandford Quality Consulting

"Risk Management; A MUST in today's global economy"
Dr Robert Schiff PhD RAC, CQA

SCHIFF & COMPANY, INC. Chief Executive Officer


"GMP and Compliance in the Drug Industry"
Paul G Ranky, PhD

NJIT

"Some Methods and Technologies for Creating More Sustainable & Greener Quality Enterprises"
2:30 – 3:00 pm

ICE CREAM CHRISTIAN LOUBOUTIN STIEFEL REFRESHMENT BREAK / NETWORKING / EXHIBITS

Session D

3:00 – 4:00 pm
Vic Nanda

Manager, Process & Quality Broadband Mobility Solutions IT, Motorola

"Lean Documentation"
Rosanna Dorazio

The Franklin Covey Company


“Improving Quality by Building Trust”
Dr. Steven Ostrove

Medical devices/ Pharmaceutical

"Quality by Design (QbD) versus Validation"
David Herron

David Consulting Group

"Software Quality Best Practices"




2009 Conference Schedule:
TIME TRACK ONE - Lean TRACK TWO - Reliability TRACK THREE - FDA Regulated TRACK FOUR - Focused Quality Initiatives
ROOM Salon D Gallery Hanover Salon C
MODERATOR Bob Spinosa John Finno Carl Perini Marc Saperstein
7:20 - 8:20 am REGISTRATION, CONTINENTAL BREAKFAST, NETWORKING
8:20 - 9:20 am

KEYNOTE SPEAKER: Brian Hughitt  
National Aeronautics and Space Administration (NASA), Manager of Quality Assurance
"LESSONS LEARNED FROM CATASTROPHIC MISHAPS AND THE BIG DIG"

9:30 - 10:30 am Kevin Duggan

President, Institute for Operational Excellence

 "Operational Excellence, the Destination of the Lean Journey"
 
Adam Hilburn

Reliability Engineer, US Army

"Process to Identify Failure Modes and How to Design them Out"
Jeff Werrmann

Sr. Director, Global IT Quality & Compliance, Celgene Corp.

"Risk-Based Validation Approaches in the Pharmaceutical Industry"
Dominick Carra

US Army - Malcolm Baldrige National Quality Award (MBNQA) 

"Future Direction of the US Army Armament Research, Development and Engineering Center (ARDEC)"
10:30 - 10:45pm

COFFEE BREAK / NETWORKING / EXHIBITS

10:45 - 11:45 am Kirk Paluska
 
Consultant, Lean Transformation Group

 "VSM to Support Lean Transformation in Service" 
Fred Schenkelberg

Independent Consultant

"Misuse of MTBF"
Dr. Rowland Yovonie

Group Leader, Quality Engineering & Statistical Support, Hoffmann La-Roche

 "Pharmaceutical Quality by Design in R&D"
Mitchell Bomus

Chief Lean Six Sigma Competency Officer, US Army

"Self Sustaining
Improvement Projects"
11:45 - 1:30 pm

LUNCH / EXHIBITS / NETWORKING

1:30 - 2:30 pm Drew Locher

Managing Director, Change Management Associates

"The Complete Lean Enterprise (office & service)" 
John Smisek

Master Black Belt, US Army

 "
Improvement in Design Effectiveness and Efficiency"
Bob Seltzer

Compliance Manager,
Schering-Plough

"ASQ Certified Professional Pharmaceutical GMP Professional Certification"
Darin Wright

Consultant
STRATEGIC/SITE, LLC

"Strategic Execution through Project Management"
2:30 – 3:00 pm

ICE CREAM REFRESHMENT BREAK / NETWORKING / EXHIBITS

3:00 – 4:00 pm Gene Burk

Senior Member, Institute for
Operational Excellence

"Creating Mixed Model Value Streams Workshop"

 

Dr. Jason Cook

Chief, Reliability Management Branch, US Army

"
Physics of Failure Analysis; Probabilistic Technology; Human Capital Investment"
Dr. Ulo Palm

Vice President Clinical Planning & Operations, Forest Laboratories

"Proposal For A US National Quality Standard For Biomedical Research"
Don Holmes

President, Stochos Inc

"Automated Model Free On-Line Process Improvement Techniques with Live Demonstration"