Today, with trainers and consultants in 33 states and 14 countries,
SAM is the leading North American company in performance improvement
programs. We help our clients successfully compete in the global
marketplace.
Here are a few of our
qualified instructors:
STANLEY
A. MARASH, Ph.D., P.E., Chairman Emeritus of STAT-A-MATRIX,
consults and lectures throughout the world to heads of state and
corporations on regulatory and conformance processes, Six Sigma,
and reinventing government. Ph.D., management; M.B.A., baccalaureate,
applied statistics; CQE; CRE; Chairman Emeritus and Founder of
Quality New Jersey; former Baldrige Examiner; Founder and past
Chairman of the World Quality Council; Fellow, ASQ; recipient
Ellis R. Ott Award.
ERNANI PIRES,
President of STAT-A-MATRIX, has more than 35years of experience in corporate-wide
TQM, including manufacturing and service environments, and extensive
experience in quality assurance, quality control, testing and
inspection, auditing, and supplier performance. He assists organizations
in improving corporate performance using tools and techniques
of Six Sigma.
RANDY
CANFIELD, Master Black Belt, specializes in the design
and implementation of management systems using cross-functional
teams, change management, supplier quality improvement, customer
interface, program management, strategic planning, auditing, and
reliability engineering. His expertise includes executive management
reporting; customer surveys and employee feedback; hoshin planning,
kanban, and balanced scorecard; SPC; ISO 9000; and customer-driven
technical problem solving and supplier quality support.
JOSEPH DECARLO, Management
Consultant, has more than 20 years experience in quality, sales,
business development, marketing, and operations. His particular
areas of expertise include problem solving, team leadership and
facilitation, business process improvement and quality management
systems, and Voice of the Customer. He holds a B.S. in Electrical
Engineering and is a past Executive Chairman of the Danbury, CT
ASQ.
ROBERT J. EATINGER, P.E.,
Management Consultant, has extensive DoD management and engineering
experience assuring the quality and reliability of scientific
computing systems and Navy Tactical Training Range Instrumentation.
He was the quality technical agent for the Navy's Strategic Systems
Programs, supporting Polaris, Poseidon, and Trident. M.S., systems
management; B.S. electrical engineering; Certified Lead Auditor;
Member, ASQ.
DIANE FAGLON, Management Consultant,
is a specialist in quality management systems, process management,
customer satisfaction and Balanced Scorecard, with 38 years experience
in the telecommunications and technologies sectors. Her background
includes active participation in the development of the TL 9000
telecommunications standard and extensive experience in Baldrige
and EFQM systems, ISO 9001 initiatives, and LEAN initiatives.
She led the design and implementation of various types of Baldrige
and European Quality Award assessment options both in the US and
Europe. In addition, Diane served as the past Chairperson of the
New Jersey Governor’s Award for Performance Excellence from
1995 through 2001, and Senior Examiner on both Baldrige and New
Jersey management system evaluation teams.
HANK FAHRLANDER, P.E.,
Management Consultant, specializes in ISO 9000 quality systems,
TQM, and SPC. Over 35 years of experience in quality management,
including engineering and senior management positions involving
manufacturing operations, product and process improvement, and
vendor certification. B.S.E.E.; Registered Lead Auditor; VDA Lead
Auditor; CQE; CRE; Senior Member, ASQ.
MICHAEL F. FLYNN, Executive
Director, Consulting Services, Master Black Belt, has successfully
applied modern techniques to continuous improvement of business
processes. Over 20 years of experience in metals, foods, packaging,
chemicals, and pharmaceuticals. Expertise in course design and
delivery, Six Sigma, TQM, ISO 9000, SPC, experimental design,
system documentation, and reliability. M.S., B.A., mathematics;
CQE.
JAMES J. GERARD, P.E.,
Management Consultant, develops, implements, and instructs in
supplier performance efforts, negotiation, conflict resolution,
management of contracts, and on-site audits. Over 30 years in
the telecommunications industry in quality assurance using principles
of TQM, Baldrige criteria, and other quality awards. M.B.A., B.E.E.,
A.A.S.; Certified Lead Auditor.
PETER GREY, Ph.D., Management
Consultant, Master Black Belt and Lean Enterprise Practitioner,
specializes in ISO 9000 and ISO 14000 management systems, Lean
Enterprise, and Six Sigma. He has more than 25 years of experience
in research, problem solving, Six Sigma, Lean Enterprise, and
leadership of implementation teams in planning, training, and
auditing for ISO 9000 registration, Lean Enterprise, and Six Sigma.
Member, ASTM, ASQ.
JAMES HARDY, Management Consultant,
has more than 20 years of experience as a trainer and auditor
in many different industries, including aerospace, chemicals,
plastic injection-molding, metal fabrication, and others. He specializes
in training and coaching relative to business process improvement
and ISO 9001/AS9100 management system design, implementation,
and audit. Registered QMS Auditor; Certified AS9100 Aerospace
Experienced Auditor; CQE; Senior Member, ASQ.
MICHAEL H. HELD, Management
Consultant, specializes in lead/internal auditing and quality
systems documentation training, and on-site ISO 9000 consulting,
auditing, and training. Over 25 years of experience in manufacturing,
quality, and executive management. M.S., management engineering,
B.S.E.E.; Registered Lead Auditor; Senior Member, ASQ.
HYMAN KATZ, Ph.D., Management
Consultant, has spent more than 30 years working with senior management
in quality management system development and conformance (ISO
9001, ISO 14001, ISO 13485, ISO 13408, etc.), regulatory negotiations,
project management, internal and external audits, technical writing,
product development, Sarbanes-Oxley 404 process mapping, and FDA
submittals. He specializes in direction and support of quality
assurance activities and regulatory requirements for medical device
and biopharmaceutical organizations.
I. ROBERT MARASH, Executive
Vice President, International and Certification Services, has
over 35 years of experience in auditing and implementing quality
management systems for ISO 9000, ISO 14000, and FDA's GMPs. Responsible
for SAM's worldwide educational services. CQA; Certified Lead
Auditor; VDA Lead Auditor; Fellow, ASQ; Member.
DAVID PATRISHKOFF, Management
Consultant, with expertise in Lean Six Sigma, process improvement,
quality management systems, and kaizen events, has been implementing
company culture transformations, performance improvements, and
change management in automotive, healthcare, manufacturing, and
transportation organizations for more than 25 years. He is a specialist
in reducing design and new product costs, and production and engineering
problems in manufacturing and service industries.
DARREN REEVES, Management
Consultant, has 15 years of industry experience in coaching and
training in quality and regulatory assurance for medical device
and pharmaceutical companies. He has provided sterilization and
process validation and engineering expertise in large and small
FDA-regulated organizations. His specialty areas include document
control systems, corrective and preventive action (CAPA) programs,
FDA QSIT regulatory conformance for devices, validation programs,
third-party assessments, HACCP analysis, and sterilization services.
He has an MBA and a B.S. in biology.
CARL RICHARDS, has more than
20 years of experience in developing, managing, and implementing
computer system quality assurance and compliance projects worldwide.
He has developed master validation plans and quality policy standards
for FDA-regulated companies and has performed compliance evaluations
of existing computer system environments and documentation against
applicable regulatory and internal standards and FDA guidelines.
AMITA SHERWOOD , Management
Consultant, has used Six Sigma and Lean process improvement approaches
to improve quality and service in information technology, financial
services, and government organizations. She has experience leading
and participating in cross-functional process improvement efforts,
leading Six Sigma and Lean program deployments, and training and
coaching project teams. She also has experience with facilitation
and team skills, and organizational change management. Amita earned
her B.S. in Management Science and Information Systems from the
Pennsylvania State University.
JAMES SZELC, Management Consultant,
has more than 30 years of federal government regulatory experience.
As a former FDA investigator, he has conducted inspections and
investigations of medical device manufacturers in the United States
and internationally, including medical devices ranging from Class
l, GMP Exempt to Class ll and Class lll devices requiring PreMarket
Approval (PMA) or 510(k) submission, and has conducted audits
of textile, orthopedic, and other electromechanical device manufacturers.
CHARLES M. VALENTINE,
Management Consultant, has extensive experience in the medical
device industry including development and manufacturing engineering,
quality engineering, and quality assurance. His background includes
test design engineering, supplier quality, ISO 9000 quality system
design and implementation, quality field evaluation, and product
design, development, and evaluation. M.S.E.E.; M.B.A.; B.S.E.E.;
Registered Lead Auditor.