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QUALITY IN THE TRIANGLE CONFERENCEPerpetual Quality - From Concept to Continuous Performance VerificationMay 5, 2016
ASQ Raleigh Conference May 2-5, 2016
North Carolina State University
McKimmon Center
1101 Gorman Street
Raleigh, NC 27606
ASQ RALEIGH SECTION 1113
PO Box 5589
Cary, NC 27512-5589
2016With Pre-Conference
WorkshopsMay 2-4, 2016
REGISTER NOW www.asqraleigh.org
ASQ-RALEIGH’S 2016 QUALITY IN THE TRIANGLE CONFERENCEPerpetual Quality— From Concept to Continuous Performance Validation
Thursday, May 5, 2016With Pre-Conference Workshops Monday, May 2, 2016 - Wednesday, May 4, 2016
REGISTER NOW: www.asqraleigh.orgEarly Bird Registration ends April 28, 2016
For more information about the conference and pre-conference workshops contact:Mike Porter ASQ Raleigh Conference [email protected] Office: 919.456.5490 or Mobile: 910.813.4663
REGISTER NOW! www.asqraleigh.org
ASQ-RALEIGH PRE-CONFERENCE WORKSHOPSPre-Conference Workshop, Mon. & Tues., May 2 -3WRITING EXCEPTIONAL AUDIT REPORTS
Mary Chris Easterly, Global Quality Auditor, Merck
8:00 am - 5:00 pm (includes lunch and refreshments)
$300 Early bird Registration fee through April 28, 2016
$325 Regular Registration fee begins April 29, 2016
ASQ Members who participate in this ASQ Raleigh workshop
will receive 1.4 RUs. Student discount available.
Pre-Conference Workshop, Wed., May 4DESIGN OF EXPERIMENTS MADE SIMPLE Mark Crossley, President and Principal Consultant, Quality Management Associates, Inc.
8:00 am - 5:00 pm (includes lunch and refreshments)
$150 Early bird Registration fee through April 28, 2016
$175 Regular Registration fee begins April 29, 2016
ASQ Members who participate in this ASQ Raleigh workshop
will receive .7 RU. Student discount available.
QUALITY IN THE TRIANGLE CONFERENCEPERPETUAL QUALITY - FROM CONCEPT TO CONTINUOUS PERFORMANCE VERIFICATION
McKimmon Center Floorplan
2
Registration Fees Member Non- Member
Retired Member
Student
Early Bird Registration Fee: Ends April 28, 2016
Conference
Thurs, May 5, 2016$99 $99 $99 $75
2-Day Workshop
Mon-Tues, May 2-3, 2016$300 $300 $300 $250
1-Day Workshop
Wed, May 4, 2016$150 $150 $150 $125
Regular and On-Site Registration Fee: Starting April 29, 2016
Conference
Thurs, May 5, 2016$125 $125 $125 $99
2-Day Workshop
Mon-Tues, May 2-3, 2016$325 $325 $325 $275
1-Day Workshop
Wed, May 4, 2016$175 $175 $175 $150
ASQ Members who participate in the ASQ Raleigh Conference receive 1.0 RU.
ASQ Members who participate in the ASQ Raleigh Workshops receive –0.7 RU for each day of a workshop
2016MAY 2-5, 2016
North Carolina State University McKimmon Center 1101 Gorman Street Raleigh, NC 27606
CONFERENCE AT-A-GLANCE
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Monday & Tuesday, May 2-3, 2016 2-Day Pre-Conference Workshop (including refreshments/lunch)
8:00 am – 5:00 pm Writing Exceptional Audit Reports Mary Chris Easterly, Global Quality Auditor, Merck
Wednesday, May 4, 2016 1-Day Pre-Conference Workshop (including refreshments/lunch)
8:00 am – 5:00 pm Design of Experiments Made Simple Mark Crossley, President and Principal Consultant, Quality Management Associates, Inc.
Thursday, May 5, 2016 Quality in the Triangle Conference
7:30 – 8:00 am Conference Registration, Continental Breakfast, and Exhibits
8:00 – 8:05 am Welcome Mike Porter, ASQ Raleigh Conference Chair,
Senior Director, Clinical Supplies QA, PPD Mark Morton, ASQ Raleigh Section Chair and Objective Business Solution Provider, First Citizens Bank
8:05 – 9:20 am Opening Keynote: Networking for Mutual Benefit
Teddy Burriss, LinkedIn Trainer and Coach, Burriss Consulting, Inc.
9:20 – 9:35 am Exhibits and Networking
CONCURRENT SESSIONS - 1A, 1B, 1C
9:35 – 10:45 am 1A: Building a House of Quality One Brick at a Time
Chris McMillian, Sr Corporate Performance Analyst, City of Fayetteville, NC
1B: Using Continual Monitoring to Identify, Investigate and Prevent / Remediate ELISA Method Failures Julie Smith, Technical Expert in Product Safety, Syngenta
1C: If I am Talking, You Must be Listening: Helping Improve Your Presentation Skills
Luis Morales, Director, ASQ Region 11B
10:45 – 11:00 am Exhibits and Networking
11:00 am – 12:00 pm Keynote Address: Trending the Future of Quality Management
Dr. Joseph A. DeFeo, Chairman & CEO, Juran Global
12:00 – 1:00 pm Lunch, Exhibits and Networking
CONCURRENT SESSIONS - 2A, 2B, 2C
1:00 – 2:10 pm 2A: Forming an Inter-Dependent Quality Culture
Margaret Lewandowski, Product Stewardship Manager, BASF Crop Protection
2B: Technology Transfer and Preparing for Process Validation [A Case Study] John Wass, CPIP, Technical Consultant & Project Manager, Commissioning Agents, Inc. (CAI)
2C: Determining the Level of Confidence for a Statistic (from Sample Data)
Mark Crossley, President and Principal Consultant, Quality Management Associates, Inc.
2:10 – 2:25 pm Exhibits and Networking
CONCURRENT SESSIONS - 3A, 3B, 3C
2:25 – 3:35 pm 3A: Successful Quality Audits: A 360 Degree View
Mary Chris Easterly, Global Quality Auditor, Merck
3B: ASQ 101: Raleigh Chapter Overview and Opportunities
Mark Morton, ASQ Raleigh Section Chair
Fred Rich, ASQ Raleigh Section Recertification Chair
Byron Wingerd, ASQ Raleigh Section SIG Six Sigma Chair
Carol Poindexter, ASQ Raleigh Section Executive Quality Round Table Chair
3C: That was Then. This is Now. Linda Bankoski, President,
Quality Leadership Associates
3:35 – 3:40 pm Break
CLOSING REMARKS
3:40 – 4:55 pm Closing Keynote: How to Improve Quality by Becoming a Person of Influence
Tom Cooper, PMP, Speaker, Trainer & Coach, Brighthill Group
4:55 – 5:00 pm Brief Closing Remarks Mike Porter, ASQ Raleigh Conference Chair
Senior Director, Clinical Supplies QA, PPD
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Pre-Conference Workshop 1 WRITING EXCEPTIONAL AUDIT REPORTS Mon., May 2 and Tues., May 3 2016, 8:00 am – 5:00 pm Includes Lunch and Refreshments | ASQ Members who participate in this
ASQ Raleigh workshop will receive 1.4 RUs.
Workshop Leader: MARY CHRIS EASTERLY, Global Quality
Auditor, Merck
You conducted a thorough audit: observed processes, reviewed
procedures and records, and interviewed personnel. How do you
communicate the results to gain the maximum benefit? By
writing a clear, well-written audit report.
Ineffective audit reports:
• Inhibit continuous improvement of the evaluated systems,
• Lead to confusion about requirements, and
• Waste time addressing insignificant issues.
Exceptional audit reports:
• Communicate gaps in compliance to the audit sponsor, and
• Facilitate the auditee’s response to gaps in compliance,
identifying appropriate corrections, corrective actions, and/or
preventive actions.
Attendees will identify the crucial elements of an exceptional
audit report, review examples of poorly written observations, and
practice writing unambiguous observations (gaps in compliance).
A workbook and electronic templates are provided.
Note: Most examples provided are from ISO 9001 or pharmaceutical/
medical device good manufacturing practices audits, but principles
presented apply to reports for any type of audit.
About the Workshop Leader: Mary Chris
Easterly (CQA, CMQ/OE, CPGP, Past ASQ
Raleigh Section Chair) is a global quality
auditor at Merck with 29 years of experience
in FDA regulated industry. She was one of the
reviewer for the 4th edition of CQA handbook
and has taught CQA exam preparation
courses. This workshop has been held at five
ASQ Audit Division Conferences.
Pre-Conference Workshop 2DESIGN OF EXPERIMENTS — (DOE) MADE SIMPLE
Wed., May 4, 2016, 8:00 am – 5:00 pm Includes Lunch and Refreshments | ASQ Members who participate in this
ASQ Raleigh workshop will receive .7 RU.
Workshop Leader: MARK CROSSLEY, President and Principal
Consultant, Quality Management Associates, Inc.
This workshop presents a unique and easy method for performing
and analyzing Design of Experiments (DOEs). No complicated
statistics are required. DOE is the “rock” upon which the whole
Six Sigma approach works.
• Do you want to determine what is affecting your process variation?
Do you want to know what is causingyour high defect rate?
• Do you want to know what factors are are important in your
process inorder to improve it ?
All of these questions can be answered using Design of Experiments.
No statistical software is required! This class will feature simulations
using the 11 factor DOxSim. Loaner calculators will be provided along
with handouts.
About the Workshop Leader: As president and
principal consultant for Quality Management
Associates, Inc., Mark Crossley provides
technical expertise and training in the
application of statistical methods for quality
improvement. His skills are the culmination
of over thirty years’ experience as a quality
manager, quality engineer, and internationally recognized consultant.
He has taught numerous seminars for the national American
Society for Quality on topics including Quality Engineering, Design
of Experiments, Statistical Process Control, and Advanced Topics in
SPC. He has developed award-winning methods of instruction and
twice been the recipient of the ASQ’s “Faculty Excellence Award”
for being one of their highest rated instructors. He has presented
numerous seminars at North Carolina State University, The University
of Wisconsin at Milwaukee, and the University of Kentucky.
His professional and academic credentials include a Bachelor’s
degree in Chemistry/ Mathematics and a Masters of Science in
Quality Assurance from California State University. He is the
author of The Desk Reference of Statistical Quality Methods and
is certified by the American Society for Quality as a Certified Six
Sigma Black Belt (CSSBB), a Certified Quality Engineer (CQE), a
Certified Reliability Engineer (CRE), a Certified Quality Manager
(CQMgr), and a Certified Quality Auditor (CQA). He is also a Master
Six Sigma Blackbelt and has met rigorous requirements of the
Institute of Management Consultants to be recognized as a Certified
Management Consultant.
PRE-CONFERENCE WORKSHOPS | MAY 2-4, 2016
North Carolina State UniversityMcKimmon Center 1101 Gorman Street Raleigh, NC 27606
REGISTER NOW! www.asqraleigh.org
BRING & DONATE A CAN OF FOOD!
ASQ Raleigh Section 1113 supports the
Food Bank by sponsoring volunteer days
throughout the year and by sponsoring
a Food Drive during the Quality in the Triangle
Conference. If you would like to contribute, please bring
non-perishable food, hygiene, and paper items with you
to the conference. No glass containers, please!!
ASQ RALEIGH CONFERENCE OPENING KEYNOTEMcKimmon Center | North Carolina State University | 1101 Gorman Street Raleigh, NC 27695
OPENING KEYNOTE | 8:05 – 9:20 AM
Networking for Mutual BenefitTeddy Burriss, Certified Social Media Strategist, LinkedIn Coach, Trainer, Public Speaker and a Certified Career Transition Coach, Burriss Consulting, Inc.
ABOUT THE SPEAKER
Teddy Burriss is a Certified Social Media Strategist, LinkedIn Coach, Trainer, Public Speaker and a Certified Career Transition Coach.
Teddy is also a Dale Carnegie Graduate Coach, Practiced Toastmaster, Sandler Sales Trained Professional and a published author.
Teddy’s first two books, Networking for Mutual Benefit and Success Using Social Media are the core philosophies in all of his topics, coaching and training.
Teddy speaks to businesses, organizations, associations and higher education groups across the country on the topics related to Social Networking, LinkedIn and Networking.
Teddy volunteers up to 50% of his time helping the unemployed to learn who they truly are and how to find the next career step for them.
Networking, when done properly, creates value for our lives, careers,
businesses and communities.
As a Quality Professional working on projects and business
programs, networking can be used to discover new ideas, resources,
tools and products needed to create business success.
Incorporate networking into your life and when a career transition
becomes an idea or a reality, the people in your network can become
conduits to new career ideas and opportunities.
“Networking for Mutual Benefit is finding, developing and nurturing
relationships that mutually move people forward through life.”
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ASQ RALEIGH CONFERENCE KEYNOTE Dr. Joseph A. DeFeo, President and CEO of Juran Global
KEYNOTE ADRESS | 11:00 AM – 12:00 PM
Trending the Future of Quality Management
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ASQ-Raleigh Keynote Speaker, Dr. Joseph A. DeFeo presents his latest research on the future of quality management while working on the newest edition of the
famous Juran’s Quality Handbook. He will seek to define, with
as much precision as possible, what has changed and what will
change in the coming five years and how that may impact the
role of the quality professional.
The current trends to discuss:
• Quality management
- from the shop floor to the boardroom
- from goods manufacturers to all organizations
• Quality Methods for reducing business risk
• Paper driven processes to paperless quality systems
• Managment Small data analysis to big data analysis
• Quality professional skill sets from auditor to mentors
His key points will include:
• Where is quality management changing and not changing?
• How fast or slow will the changes be?
• How can I prepare myself as a quality professional to be an
‘indispensable contributor’ in my organization?
ABOUT THE CONFERENCE KEYNOTE SPEAKER
Dr. Joseph A. DeFeo, President and CEO of Juran Global, is
one of the world’s recognized, leading experts on operational
excellence methods and breakthrough management principles.
For almost thirty years, Dr. DeFeo has worked as a trusted
adviser helping business leaders increase sales, reduce costs,
and improve customer satisfaction through the deployment of
performance excellence programs such as Business Process
Management, Lean, Six Sigma, Strategic Planning and Cultural
Change Management.
Building on universal principles pioneered by quality guru, Dr.
Joseph Juran nearly sixty years ago — infusing current thinking
into new strategies to drive performance excellence and
transformational change — Dr. Defeo transformed the Juran
Institute into Juran Global to support a new age of business
improvement.
Dr. DeFeo is the co-author of two new leadership books:
Juran’s Quality Essentials: for Leaders and Juran’s Quality
Management and Analysis, 6th Edition. DeFeo’s belief that
a relentless customer focus and integrity drives business
results was recently noted by Steve Denning of Forbes.com.
“By re-focusing primary attention on the customer and on
exceeding the customer’s expectations, the Juran Quality
Handbook has done quality management a great service.”
A frequent motivational guest speaker at international
conferences, Dr. DeFeo has presented in over 30 countries.
To Register: www.asqraleigh.org Or contact: ASQ Raleigh Conference ChairMike Porter [email protected]. Office: 919.456.5490Mobile: 910.813.4663
CONCURRENT SESSIONS 1A, 1B, 1C | 9:35 – 10:45 AM
SESSION 1A BUILDING A HOUSE OF QUALITY ONE BRICK AT A TIME
How do you build a performance measurement and quality management system from scratch? How do you introduce
such a system into a service environment where most of the people are not quality savvy? How do you convince
management of the benefits of managing based on performance data and how do you convince them to use proven
quality principles to improve performance. Attend this session and learn how the City of Fayetteville , North Carolina
is answering these questions and more as it continues to build its house of quality brick by brick. This session will
outline Fayetteville’s quality journey and will highlight specific methods and tools the City is using to transform City
Government into a high performing organization through the use of performance and quality management.
CHRIS MCMILLIAN, Senior Corporate Performance Analyst, City of Fayetteville, NC
About the Speaker: Chris has over 20 years of experience in application development, process
improvement, and project management. He has worked in both the public and private sector, and in
both large corporate and small business settings. He has Masters degrees in Project Management
and Business Administration, is a Certified Six Sigma Black Belt through the American Society for
Quality, and has completed the ITIL Intermediate Lifecycle Series of Exams. He currently works in
strategic planning and quality improvement for the City of Fayetteville, NC.
SESSION 1B USING CONTINUAL MONITORING TO IDENTIFY, INVESTIGATE AND PREVENT / REMEDIATE ELISA METHOD FAILURES
Enzyme-linked immunosorbent assay (ELISA) methods are an industry standard technique for specific, sensitive
protein quantitation. The scientific principles underlying this technology are straightforward. However, technical
challenges may arise during development, validation and transfer for each specific protein method and matrix. Even
after an ELISA method is validated, the ELISA method life cycle continues with an effective assay monitoring program
to assure method performance consistency. Monitoring ELISA method performance further ensures preventive
actions in case inconsistencies have been identified. This principle of continual performance verification is applicable
to a wide variety of analytical test methods. Strategies to qualify and incorporate meaningful assay controls that
improve test method reliability will be shared. In addition, case studies using assay monitoring to identify changes in
test method performance resulting from equipment failure, critical reagent variability or even operator training will
be reviewed.
JULIE SMITH, Technical Expert in Product Safety, Syngenta
Julie Smith earned her B.S. from the University of California, Davis, and her Ph.D. from North
Carolina State University. Julie earned additional certifications include ASQ CQA and Six Sigma
Greenbelt. Her expertise includes developing, validating and monitoring analytical methods in
pharmaceutical and agricultural biotechnology fields.
Main Conference Sessions Thursday, May 5, 20162016 Quality in the Triangle Conference
7
CONCURRENT SESSIONS 1A, 1B, 1C | 9:35 – 10:45 AM (continued)
SESSION 1C IF I AM TALKING, YOU MUST BE LISTENING: HELPING IMPROVE YOUR PRESENTATION SKILLS
As public speakers, we make the assumption that if we are speaking and the audience is looking at us, they must be
listening. This assumption is not always true. During this presentation, we will review dangerous assumptions that
speakers make about their audience and strategies to help clarify those assumptions. You will receive tips on how to
make sure your message reaches everyone in the room, learn how to improve your platform skill and enhance your
message, discuss tips for successful visuals that support your message, and learn ways to handle questions from your
audience. And, we will even discuss how to prepare for an encounter with a hostile audience.
LUIS MORALES, Director, ASQ Region 11B
About the Speaker: An ASQ member since 1995, Luis Morales has nearly thirty years of leadership,
change management, and project management experience in the federal, health, business and
IT sectors. Luis is a Senior Member of ASQ and holds three ASQ certifications: Certified Quality
Improvement Associate, Certified Six Sigma Green Belt and Certified Manager of Quality &
Organizational Excellence. Luis has served as Chair for Section 1104 (Richmond, VA, one of Region
11B’s Deputy Regional Directors (DRD), and currently serves as Director of Region 11B.
CONCURRENT SESSIONS 2A, 2B, 2C | 1:00 – 2:10 PM
SESSION 2A FORMING AN INTER-DEPENDENT QUALITY CULTURE
The culture of a company defines its success. The most successful companies are characterized by an Inter-Dependent
Quality Culture (IDQC).
In 1950, W. Edwards Deming, was invited by the Japanese Union of Scientists and Engineers to lecture on Statistical
Process Control and concepts of quality. The Japanese adopted and adapted his methods and the quality of their
products soon created unprecedented international demand. By 2014, Toyota was the eleventh largest company in the
world by revenue. .
Du Pont has long been recognized as a leader in safety. They’ve credited their success to the company’s
interdependent safety culture. Applying DuPont’s principles to Deming’s principles of quality gives rise to IDQC. In
late 2013, the BASF’s Crop Protection’s Operations Leadership Team designed their strategy with the creation of an
Interdependent Quality Culture as the central pillar.
Their ultimate goal was increased customer satisfaction through quality of products, processes, and organization. To
reach this goal, we needed to make a cultural change from a dependent organization to an interdependent one. This
paper outlines our journey through this cultural change.
MARGARET LEWANDOWSKI, Product Stewardship Manager, BASF Crop Protection
About the Speaker: Margaret Lewandowski, Product Stewardship Manager, BASF Crop Protection,
(BA Chemistry, Rutgers College. MS, Ph.D. Toxicology NC State), joined BASF in 1988 as a scientist
in Animal Metabolism, before transitioning to EHS, then moving to Product Stewardship in 1997.
Since 2013, she has led the Inter-Dependent Quality Culture (IDQC) strategic initiative.
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MAIN CONFERENCE SESSIONS: 1C, 2A, 2B, 2C
SESSION 2B TECHNOLOGY TRANSFER AND PREPARING FOR PROCESS VALIDATION [A CASE STUDY]
Have you thought about having to apply QbD concepts to a legacy product transfer? What additional challenges
would exist if the Receiving Unit were half way around the world or had atypical equipment, resource, and cultural
constraints?
We will use a product transfer case study from the U.S. to India of a terminally sterilized emulsion product in glass vial
as a forum to discuss these challenges. We will cover in detail all the key components necessary to define a robust
control strategy, as well as provide example data sets and tools from a process centric perspective. Cross-functional
team leadership and business drivers will be covered briefly to bridge the gap from transfer strategy and program
management to process science and project execution. Complementary industry standards and models that added
value to this project will be referenced with rationale but will not be covered in detail (e.g. ANSI/ISA S88).
JOHN WASS, CPIP, Technical Consultant & Project Manager, Commissioning Agents, Inc. (CAI)
About the Speaker: John Wass is a technical consultant and project manager for Commissioning
Agents, Inc. (CAI), a Certified Pharmaceutical Industry Professional (CPIP). Over the past decade he
has participated in many stages of the product development lifecycle from concept to new market
commercialization, and has implemented enterprise quality data management and manufacturing
process control systems in support of these product processes. Recently John has been engrossed
in the technology transfer of a legacy product to an international greenfield facility where a retrospective QbD
approach was being employed. Prior to this project he served in a project management role focusing on off-market
and drug shortage product re-launches, as well as global expansion of on-market products to new international
markets. Prior to CAI, he worked for a start-up medical device company specializing in the development of in situ
polymerizing hydrogels as internal sealants, where he actively participated in the development, characterization, and
ultimate commercialization of novel products. John earned his B.Sc. in Chemistry with a specialization in ACS certified
Biochemistry at the University of Virginia, where he researched solid phase extraction techniques for application in a
fully integrated microdevice capable of genetic analysis.
SESSION 2C DETERMINING THE LEVEL OF CONFIDENCE FOR A STATISTIC — FROM SAMPLE DATA
All of the data we collect for “quality” is ultimately converted into a statistic - average, standard deviation, process
capability index, measurement error - to name a few. What we fail to do (in many cases) is to express a degree of
error with these statistics. What we really should be doing, is to admit that we really don’t have the truth, but we are
perhaps really close. All good quality engineers should provide a “statistical disclaimer” such as “I don’t know the
true but I am percent confident it is between and ” after all
statisticians don’t really know anything for certain, they are just very confident. This presentation will give some
real time examples on how to determine levels of statistical significance. Mark is known for giving very dynamic and
hands-on sessions.
MARK CROSSLEY, President and Principal Consultant, Quality Management Associates, Inc.
About the Speaker: Please see Mark Crossley’s PreConference Workshop 2 for more information
about this speaker.
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CONCURRENT SESSIONS 3A, 3B, 3C | 2:25 – 3:35 PM
SESSION 3A SUCCESSFUL QUALITY AUDITS: A 360 DEGREE VIEW
Auditors and auditees would like audits to be successful, achieving the ultimate shared goal of ensuring that the product
or service meets quality requirements and customer needs. What can you do to ensure a quality systems audit by a
customer or certification body (or an inspection by a regulatory authority) is successful?
AUDITEE: If you are hosting an audit, participating on the audit team, or presenting information to an auditor, what
actions should you take before and during the audit to ensure a positive outcome?
AUDITOR: If you are conducting the quality systems audit, what can you do before, during, and after the audit to
effectively assess quality systems and communicate results to the auditee?
This presentation provides the methods and tools you can use to ensure every audit runs well from the perspectives of the
auditor and the auditee. Pharmaceutical quality systems are used to demonstrate the principles, but the same concepts
apply to any organization that must comply with a set of requirements.
MARY CHRIS EASTERLY, Global Quality Auditor, Merck
About the Speaker: Mary Chris Easterly (CQA, CMQ/OE, CPGP, past Raleigh section Chair), global
quality auditor at Merck, has 29 years of experience in the pharmaceutical/medical device industry.
She reviewed the CQA handbook (4th edition), contributed to the CPGP handbook, and is writing
questions for the new Certified Supplier Quality Professional exam.
SESSION 3B ASQ 101: RALEIGH CHAPTER OVERVIEW AND OPPORTUNITIES
Mark Morton, ASQ Raleigh Section Chair, will begin this session with an ASQ Raleigh Section overview. Fred Rich,
Section Recertification Chair, will continue the discussion highlighting the certifications offered by ASQ and
offer a brief review of the key elements required for maintaining ASQ certifications, including do’s and don’ts for
recertification. Fred will also talk about some of the common questions asked about both topics. Byron Wingerd,
Section SIG Six Sigma Chair, will discuss the forums held for six sigma and lean. He will talk about some of the
discussion topics led by facilitators noting their goal to generate two-way dialog and best practice sharing. Carol
Poindexter, Executive Quality Round Table Chair, will discuss the newly formed Executive Quality Round Table program
that meets 4-5 times a year.
MARK MORTON, ASQ Raleigh Section Chair
About the Speaker: Mark Morton has been an ASQ member since 2007. Through ASQ he has been
certified as a Quality Improvement Associate (CQIA) as well as a Six Sigma Black Belt (CSSBB).
Throughout his career he has been involved with activities centered on improving the current state
of processes and organizations. He is the 2016 ASQ Section 1113 chair. Mark works at First Citizens
bank in Raleigh where he practices continuous improvement methods daily with his colleagues.
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MAIN CONFERENCE SESSIONS: 3A, 3B, 3C
FRED RICH, ASQ Raleigh Section Recertification Chair
About the Speaker: Fred Rich has been an ASQ member since 2007 and is a certified Six Sigma
Black Belt and Quality Manger. He has been Co-Chair of the Six Sigma Special Interest Group for the
last three years and is now the Recertification Chair. Fred has worked at Gregory Poole Equipment
Company for 32 years and is currently the General Manager of Parts Operations and a corporate Six
Sigma Master Black Belt.
BYRON WINGERD, ASQ Raleigh Section SIG Six Sigma Chair
About the Speaker: Byron Wingerd is the Section Chair for ASQ Raleigh SIG Six Sigma and is a
Senior JMP Systems Engineer at SAS.
CAROL POINDEXTER, ASQ Raleigh Section Executive Quality Round Table Chair
About the Speaker: Carol Poindexter has been an ASQ member since 1990 and has served in several
positions on the Leadership Council. She has served as Treasurer and interim Secretary. She is now
the chair for a newly formed ASQ Section 1113, Executive Quality Roundtable which was started 2015.
She has been certified as a Certified Quality Auditor (CQA). Carol is the Director of GMP and Quality
Systems for Companion Diagnostics with LabCorp/Covance.
SESSION 3C THAT WAS THEN. THIS IS NOW.
Using quality management and improvement principles and techniques should be a practical. Whether you work at
home, in manufacturing or any other organization that seeks to be successful in their endeavors—quality principles
should help us achieve our goals, not impede them. In this session, Linda will provide you with new ways to (1) consider
the requirements of ISO 9001:2015, (2) use them as tools to find opportunities, risks, and (3) understand how quality
technique can improve your work and life.
LINDA BANKOSKI, President, Quality Leadership Associates
About the Speaker: For over thirty years, Linda Bankoski, President, Quality Leadership Associates
has developed a passion for customer service, learning, and improvement. She has worked as an
auditor, trainer, and consultant in a wide variety of manufacturing, service, government, healthcare,
hospitality, and not-for-profit organizations. She has served as an RAB/QSA lead assessor for over
twenty years and on the Board of Examiners for Baldrige National Quality Program for five years.
Linda regularly develops and teaches courses and workshops on the ISO 9000 standard,
cGMP, system auditing, problem solving, team building, customer service, quality management and organizational
effectiveness and improvement. She teaches Six Sigma with Lean for Delaware Manufacturing Extension Partnership.
Linda loves helping others learn and believes that applying quality management to life is the true goal. She believes
that changes and adaptations are necessary to achieve Excellence.
11
The 2016 ASQ Quality in the Triangle Conference Sponsors
Please learn more about these Quality Organizations and take time to stop by their exhibits on Thursday, May 5, 2016, during the ASQ Raleigh Conference.
12
ABOUT THE CONFERENCE KEYNOTE SPEAKER
Tom Cooper, PMP (Project Management Specialist)
started his career as a computer science geek who
spent a couple of decades leading software and
technology initiatives in companies from startups to
Fortune 500.
Today Tom is a speaker, trainer and coach helping
clients as improve quality in their products by
improving their ability to communicate clearly,
delegate effectively and manage conflict well.
ASQ RALEIGH CONFERENCE CLOSING KEYNOTE Tom Cooper, PMP, Speaker, Trainer & Coach, Brighthill Group
You can have the best SOPs, and CAPAs in the world, and it won’t
make a difference if you can’t influence others to implement your
ideas. The great news is that anyone can learn how to become a
person of influence.
In this dynamic and interactive session we will talk about the
fundamentals of growing your influence with others and cover a
framework that participants can use to improve their influence
with others.
Participants will leave with at least three actionable ideas to help
them engage others and encourage them to change.
CLOSING KEYNOTE | 3:40 – 4:55 PM
For more information, contact:
Mike Porter, ASQ Raleigh Conference Chair
Office: 919.456.5490 or Mobile: 910.813.4663
How to Improve Quality by Becoming a Person of Influence
